Apparatus, systems and methods for transvascular access to the brain

ABSTRACT

The present disclosure discusses a devices, systems and methods for transvascular, transvenous and/or transdural access, to the brain parenchyma, subarachnoid or subdural spaces. In some embodiments, the disclosed systems and methods may be used for local drug delivery, tissue biopsy, nanofluidic or microelectronic device/component delivery/insertion/implantation, in situ imaging, ablation of abnormal brain tissue and the like. Embodiments of the present disclosure include an access catheter system for extravascular procedures in the brain having an elongate, flexible tubular body, with at least one lumen extending axially there through between a proximal end, and a distal end. The access catheter system may include a side exit port and a distal end port. Further, the access catheter system may include a selective deflector positioned within the lumen configured to deflect a procedure catheter and permit a guide catheter.

REFERENCE TO CROSS-RELATED APPLICATIONS

The present disclosure claims priority to and the benefit of U.S.Provisional Application No. 62/871,976, filed on Jul. 9, 2019, which ishereby incorporated by reference in its entirety.

TECHNICAL FIELD

The present disclosure is directed towards a device, and related systemsand methods for transvascular access to extravascular spaces,particularly the brain, intracranial structures, and/or the subdural orsubarachnoid spaces.

BACKGROUND

Access to brain tissue may be required to confirm or treat neurologicdiseases involving malignancy, inflammation, aberrant circuitry, orneuropathology in general, as well as to investigate fundamentalproperties of the brain for basic science exploration. Access to samplesof intracranial tissue (i.e., for biopsy, in situ imaging, orcytological analysis) can be used to provide prognosis, tailortreatments, and monitor responses to treatment, as well as advancescientific understanding of the brain and its related functions orphysiology. In addition to being used for evaluation via methods ofhistology, in situ imaging, and cytology, access to regions of braintissue may be useful for the insertion of devices, such as probes, drugdelivery systems or apparatuses, electronic devices with tissue or mediasensing/stimulating/modulating properties (e.g., deep brain stimulators,optoelectronic devices, electrode-based microfluidic devices,cortical/intracortical arrays, or other forms of closed-loopneuromodulatory systems), or therapeutic agents (e.g., thermal ablativeenergy or chemicals, chemotherapeutics, immunonologics, or cytoactiveagents that either do not readily cross the blood brain barrier,selectively target cell-populations of interest, or may cause excessivesystemic toxicity).

Conventional methods for accessing brain tissue are invasive as theyrequire open craniotomy and/or stereotactic surgery through burr holes.Consequently, conventional methods of accessing brain tissue are proneto the complications of surgery. Complications include disfigurement,pain, perioperative infection, symptomatic hemorrhage, seizure, edema,skull and dura defects, increased length of hospital stay, patientfear/anxiety, morbidity tolerance, hospital admissions associated withhigh costs and significant rates of complications, neurologic deficits,and even death. Accordingly, the threshold for neurosurgicalintervention remains high due to either risks or physician/patientreluctance, which may in turn result in delays to diagnosis, treatment,and consequently, worse outcomes.

Further, conventional methods for accessing brain tissue may rely uponstereotactic neurosurgical methods with proxy fiducial markers, whichmay result in mistargeting, suboptimal placement, or excessivecollateral damage. Stereotactic neurosurgery may rely upon static ortemporally irresolute non-invasive imaging (e.g., pre-operative magneticresonance imaging (MRI) and/or co-registration with non-invasive imagingmodalities, linear/line-of-sight trajectories, and external fiducialmarkers to guide tissue biopsy, ablative therapies, electrode placement,and device implantation. The trajectories of endoscopic instrumentationin stereotactic neurosurgery rely on optimal burr hole drillingtechnique/execution and/or the fidelity of external fiducial markersand/or the accuracy of static or temporally irresolute image references.However, fiducial markers may physically move during the pre-operativeor intraoperative period. and are located at a distance from the targettissue, which may result in suboptimal targeting when there are minordeviations in the incident insertion angle. These and more invasivemethods may rely upon removing a cortical bone, dissection or incisionof the meninges, and gross manipulation of the brain either byretraction, resection, suction, or ablation of tissue regions ofinterest. The large and rigid instrumentation (e.g., endoscopes,cannulas, etc.) utilized in minimally invasive stereotactic neurosurgeryrelies on linear or line-of-sight trajectories to reach a target regionof interest, resulting in excessive and unwanted collateral damage,which is often a source of iatrogenic harm.

Minimally invasive catheter-based approaches to medical intervention areexperiencing rising demand due to preference by clinicians and patientsalike, and recognition by payers of the potential cost-savings to thehealthcare system. Since their inception, percutaneous catheter-basedinterventions have lowered the threshold and broadened the inclusioncriteria for diagnosing and treating disease earlier in its course andin patients with advanced disease or otherwise deemed too high risk forstandard surgical or more invasive percutaneous approaches. Moreover,percutaneous catheter-based endovascular methods of diagnosis andtreatment continue to evolve with increasing sophistication due toadvances in materials science, nano- and micro-fabrication methods,optical technology, microelectromechanical systems, and engineering thatoften compare to, or in many cases supplant, open and current state ofthe art minimally invasive surgical approaches without compromisingefficacy. Despite these technological advancements, catheter-basedneuroendovascular modes of diagnosis and treatment for non-vasculardisease remain under-developed.

In humans, the cerebral venous system courses through and overlays arange of important brain structures and provide access to a number offunctionally significant cortical and subcortical structures andrepresents a promising avenue for biopsy, ablation, targeted drugdelivery, epilepsy mapping, neuronal recording, neurostimulation,neuromodulation, and brain-machine interface. Specifically, the SuperiorSagittal Sinus, the Inferior Anastomotic Vein of Labbé, the SuperiorAnastomotic Vein of Trolard, Superficial Middle Cerebral Vein, SuperiorPetrosal Sinus, Great Vein of Galen, Internal Cerebral Veins, and theBasal Vein of Rosenthal, and their respective tributaries provideendovascular routes to the limbic structures, thalamus, basal ganglia,occipital, temporal, parietal, and frontal cortices. The diameters ofthe Superior Sagittal Sinus, Transverse Sinus, and Straight Sinus inhumans are reported to measure between 3.0 mm to 4.5 mm, 2.0 to 4.0 mm,and 1.5 to 3.0 mm (rostral to caudal), respectively. The AnastomoticVein of Labbé ranges between 2.6 mm to ˜3 mm. The deep cerebral venoussystem—namely, the Great Vein of Galen, Basal Vein of Rosenthal, andinternal cerebral veins—features rostral to caudal diameter ranges of1.84 mm to 2.32 mm, 1.72 mm to 1.78 mm, and 0.90 mm to 1.60 mm,respectively. Advantageously, the cerebral venous system is a low flowsystem with pressures ranging between 10-15 mm Hg. Compared to thearterial system, cerebral veins possess relatively large lumens due to anegligible tunica media. These low flow vessels represent a promisingavenue for transvascular access to extravascular spaces in theintracranial vault with the proposed transvascular catheter-basedapproach.

Techniques for navigating the subarachnoid space in human cadavericbrain did so with endoscopes and microcatheters from a percutaneoustranslumbar intraspinal route. These methods demonstrated atraumaticcatheter navigation through the subarachnoid space as far as theanterior fossa from a lumbar puncture site using a passive-traction,over-the-wire technique. Notably, these conventional techniques do notprovide a method for introducing endovascular catheters through systemicor extracranial vessels, advancing endovascular catheter(s) through ananastomotic vascular channel to gain access to the intracranial vascularsystem, or exiting an intracranial vascular tubular lumen viatransvascular puncture to then enter and navigate extravascular spaceswithin the intracranial vault.

Conventional techniques for transvenous access from the inferiorpetrosal sinus (IPS) into cerebellar-pontine angle cistern describe theuse a of needle encased in a sheathing component navigated over a flatrail guidewire affixed to a temporary stent. When unsheathed, the needlepenetrates across the vessel lumen and the encasing dura of the IPS forsubsequent placement of a catheter-deliverable transvenous/transduralcerebrospinal fluid shunt. The implanted shunt will have its distal endresiding in the cerebellopontine angle cistern (CPA cistern) and itsmore proximal component within the IPS lumen.

As alluded to above, these conventional techniques stabilizetranscatheter device delivery systems with the deployment of a temporarystent distal to the intended transvenous puncture site to anchor a flatrail guidewire over which the sheathed needle is tracked. Importantly,these conventional techniques rely on and exploit the anatomicalconfiguration and angle of the IPS near the CPA cistern.These-conventional techniques however are not configured for distalvenous access beyond the sigmoid sinus into more distal cerebralveins/sinuses nor are these instruments or techniques configured tonavigate to remote extravascular spaces or tissue beyond theperivascular CPA cisternal space (i.e., to/through/within brainparenchyma, or the subdural/subarachnoid compartments), nor are theseprior art techniques configured to provide maneuvers, tools, ormaterials for ensuring hemostasis after transvascular puncture and theremoval of the select transvascular instrumentation, devices, or toolsproposed herein. Pertinently, these conventional techniques solelyprovide a method for implanting and explanting a device or deliveringtherapeutics into the CPA cistern from the IPS.

Conventional methods for implantation of an intravascular electrodearray within a tubular lumen (i.e., intracranial vessel) and configuringit to operate with a tissue/media signal sense or stimulate system andrelated components do not describe a method for extravascular navigationof the intracranial vault nor do these conventional methods describedirectly sampling or accessing brain tissue for biopsy, imaging,ablation, or drug delivery.

In addition, conventional methods for recording or stimulating may onlysense or stimulate tissue or media located in close (2-5 millimeters)proximity to the blood vessel wherein it is implanted and are notconfigured to interface directly with the tissue topology over a spatialextent to capture the source, spatiotemporal evolution, or dynamics ofbiopotential signals originating from the cortical surface across acentimeter scale and/or across cytoarchitectonic boundaries, such as theproposed embodied method would enable.

Furthermore, conventional systems demonstrating transvenous deep brainstimulator insertion do not detail the requisite catheter scale,specifications, or co-axial transcatheter instrumentation, nor do theydescribe methods or devices for ensuring post-procedural hemostasis,such as those described herein. Prior-work describing remote navigationto distal cerebral veins for electrophysiology capture and/orradiofrequency ablation are maintained intraluminally and do not providethe in situ, topological precision necessary for clinical applications,such as epilepsy, cortical mapping/stimulation, biopsy, in situ imaging,thermal energy ablation, or direct drug delivery.

Conventional systems featuring a catheter design with serially placedballoons have a plurality of lateral wall ports for concentratingembolic or chemotherapeutic agents within a vessel segment of interestto concentrate cytoactive agents for improved transmural diffusion to anextravascular tissue segment of interest. These conventional methods donot allow nor are they configured for co-axial or transcatheterinstrumentation through these lateral ports. Conventional systemsutilizing serially placed balloons at the distal end of a catheter havebeen described to occlude transcutaneous stomas or lumens of thegastrointestinal and genitourinary tracts, but are not configured withthe requisite scale, materials, nor are previously discussed methodsconfigured for endovascular use, for intracranial navigation, nor dothey permit co-axial or transcatheter instrumentation from a lateralwall working exit lumen port.

Conventional catheters used for the uterus and pelvis are also limitedin that they are typically made of silicon, or with other mechanicallyweak materials that are susceptible to breakage.

Conventional systems with lateral wall or offset exit ports featuringdeployable needles or guidewires through those ports have beenillustrated for use to cross chronic total occlusions (CTOs) or forenabling biopsy of the myocardial tissue. These conventional systems areconfigured for accessing the subintimal or perivascular tissue or mediafrom the lumen of peripheral and coronary arteries. More particularly,commercially-available embodiments of conventional systems for CTOs havea stiff segment at their distal end, and are configured to providedistal pushability across stenotic or occluded segments of peripheralarteries, and are not configured for atraumatically navigating theintracranial cerebral venous system. Conventional systems fortransluminal interventions using vessel wall penetrators, required amulti-lumen design and were limited to operation in high pressurevessels.

SUMMARY

The present disclosure is directed towards a guide/access catheterdevice, and related systems and methods for transvenous access andsubdural navigation to extravascular regions of interest in theextra-axial and intra-axial compartments of the brain, includingsubdural or subarachnoid spaces, and tissue parenchyma. The devicesdisclosed herein pertain to endovascular guide/access catheters,co-axially-introduced transcatheter instruments, and transvascularlynavigated catheters for transcatheter device delivery or deployment,implantation, and drug delivery directly to extra-vascular intracranialstructures, tissues, media, and components for the evaluation,diagnosis, and treatment of neurologic disease and disorders. In someembodiments, the device may be used for targeted tissue biopsy of, insitu imaging of, device delivery to, device implantation into, or directdrug delivery to intracranial structures, such as the brain parenchyma,subdural or subarachnoid space.

Described herein is a catheter-based endovascular transvenous approachand apparatus for directly accessing the brain and its constituentcomponents. The present invention relates to a variety of methods anddevices to enable transvascular, more particularly transvenous, accessto the subdural space, subarachnoid space, and brain parenchyma withcatheters and catheter-related or delivered devices with a selectivedeflector for the diagnosis and treatment of seizure disorder, braincancer, infection, inflammation, degeneration, psychiatric disease,memory or motor impairment, and movement disorder.

The endovascular catheter proposed herein can be made from a specificset of polymers and reinforcement materials embedded within the walls ofthe catheter (such as metal alloys configured in braided or coiledpatterns, varying weave density (pitch per inch), etc.) to confer anoptimal combination of flexibility, tensile strength, torque,steerability, trackability, pushability, and compression/kinkresistance. Endovascular catheters, unlike catheters used in stomas orthrough avascular tubular structures, must be thin-walled yet confer abalance between high tensile strength, burst resistance, compressionresistance, and flexibility. The endovascular catheters disclosed hereinhave superior biocompatibility, are biologically inert (i.e., do notpromote an inflammatory response), are preferably coated withhydrophilic or lubricous materials to prevent thrombogenicity, and arenonmutagenic (non-toxic and do not contain leachable additives thatcould be cytotoxic or lead to systemic toxicity) and resist biofilmformation.

The systems and methods described herein are capable for use inlow-pressure environments. For example, embodiments disclosed herein areintended for use in the cerebral veins (low pressure) for positioning,anchoring, and supporting subsequently introduced catheters and relatedinstrumentation intended for navigating the subdural/subarachnoid space,as well as for buttressing the back propagation of forward insertionforces. Further, the present invention maintains a wide diameter lumenfrom the proximal end of the catheter through to the lateral wallworking exit lumen port where co-axial catheters may be deployed. Thisis in contrast to conventional systems in which were tailored for use inperipheral arterial systems and their lateral wall working exit lumenports feature relatively small diameters allowing only for deployment ofthin penetrators or guidewires.

Further, the disclosed embodiments, utilize advancements, such aslow-profile monolithic tubing constructs, catheters with steerability,flexible/steerable needles, and submillimeter needle-/catheter-basedfiber optic photonic or sonographic imaging apparatuses,catheter-deliverable super-elastic highly compressible shape memorymaterials or devices, wireless energy transfer/charge (e.g., near-fieldradiofrequency), solid-state micro-batteries, piezo-/tribo-electricenergy harvesting methods, injectable flexible biocompatible polymericthin film or mesh electronics, and ultracompact circuit designs (e.g.,CMOS, ASIC, etc.) provide distinct advantages to conventional systemswhich were not capable for use in connection with minimally invasivetransvascular methods and devices for the diagnosis and treatment ofneurologic disease and disorders as is described herein. The proposedmethods disclosed herein would enable improved distal navigation throughtortuous vessels, controlled transvascular access, in-situ imaging,untethered implantable devices featuring wireless energy transfer (e.g.,near field/energy-harvesting) or high bandwidth data transmissioncapabilities, as well as catheter delivery of appropriately-scaledand/or biologically compatible medical devices (e.g., cyto-compatiblecompressible shape memory alloys/materials) through relatively smallbore (2-6 Fr) catheters with equal or superior efficacy to conventionalsystems requiring invasive neurosurgery mediated primarily through burrholes or craniotomy.

In some embodiments, an access catheter system is used for extravascularprocedures in the brain. The access catheter may include an elongate,flexible tubular body, having a proximal end, a distal end and at leastone lumen extending axially there through, a side exit port positionedalong the elongate, flexible tubular body, spaced proximally apart fromthe distal end and in communication with the lumen, a distal end port incommunication with the lumen proximate the distal end, and a selectivedeflector positioned within the lumen, wherein the selective deflectoris configured to deflect a procedure catheter having a diameter greaterthan a preset threshold out through the side exit port, and wherein theselective deflector is configured to permit a guide catheter having adiameter of less than the preset threshold to pass distally beyond thedeflector and out through the distal end port.

Optionally, the selective deflector may include an inclined barrierpositioned within and partially occluding the lumen. In someembodiments, the inclined barrier includes an aperture and the aperturediameter may be less than a side exit port diameter of the side exitport. The access catheter system may also include a laterally expandablesupport carried by the elongate, flexible tubular body, and thelaterally expandable support may be positioned on an opposite side ofthe tubular body from the side exit port. Optionally, the laterallyexpandable support may include an inflatable balloon. Optionally, thelaterally expandable support may include at least one laterallydeflectable strut. The access catheter system may include a firstocclusion balloon and a second occlusion balloon, wherein the firstocclusion balloon is positioned on the tubular body on a proximal sideof the side exit port and the second occlusion balloon is positioned onthe tubular body on a distal side of the side exit port.

Optionally, the procedure catheter may include at least one of aflexible needle, a steerable needle, a retractable needle sheath, aretractable guard, a dilator, a steerable catheter, an imaging device,an ablation device, force sensors, temperature sensors, biopsy device, acompressible-expandable biopotential sensing or stimulation device orimplant, a convection-enhanced drug delivery microcatheter, or aninjectable drug eluting bioresorbable nanofluidic implant. The ablationdevice or the imaging device may include a microelectronic mechanicalsystem, optical technology, a flexible laser-cut hypotube, or co-axialactuating mechanical system. The compressible-expandable biopotentialsensing or stimulation device or implant may include a shape memoryscaffold embedded with electrodes configured to transmit to a connectorfor recoding neurons, mapping cortical activity, stimulating neurons, ormodulating cortical activity.

In some embodiments, a method of providing transvascular access to anextravascular access site in a vessel may include the steps of advancingan access catheter over a guide to position a side exit port of theaccess catheter adjacent to a target site of the vessel, retracting theguide from the access catheter, and advancing a procedure catheterthrough the access catheter and to the target side of the vessel via theside exit port of the access catheter, wherein a selective deflector inthe access catheter deflects the procedure catheter out through the sideexit port, but permits the guide to advance distally beyond thedeflector and out of a distal end of the access catheter.

Optionally, advancing the access catheter over the guide may includeadvancing the access catheter over a microcatheter or guidewire.Optionally, the vessel may include a vein. Optionally, the accesscatheter may be anchored to the target site by deploying expandablestructural members of the access catheter.

Optionally, the method of providing transvascular access may alsoinclude the steps of deploying a procedure catheter or instrumentthrough the side exit port, advancing a second device across the veinand into the target area, thereby creating a venous puncture site,advancing a wire through the second device into the target area todeploy a second procedure catheter with advanced functionality, removingthe second device, and deploying supporting expandable structuralelements of the access catheter.

In some embodiments, the second procedure catheter with advancedfunctionality may be configured to at least one of collect or delivermedia and tissue, locally image tissue, deliver materials, drugs, orcompounds, implant devices, record from neurons, modulate neuronalactivity, or ablate tissue. Optionally, deploying supporting expandablestructural elements of the access catheter may include the steps ofrepositioning the access catheter such that at least one balloon of theaccess catheter overlays the venous puncture site, inflating at leastone balloon of the access catheter such that it contacts the venouspuncture site, thereby tamponades the venous puncture site to producehemostasis, evaluating if hemostasis has been achieved by deflating theat least one balloon of the access catheter, and deploying animplantable biosynthetic, bioabsorbable hemostatic material from theside exit port responsive to determining that hemostasis from balloontamponade not being achieved. In some embodiments, the biosynthetic,bioabsorbable hemostatic material includes at least one of Poly (L)polymer, and Dextran-Sucrose-Sodium Citrate polymer.

BRIEF DESCRIPTION

The drawings illustrate the design and utility of embodiment(s) of thepresent disclosure, in which similar elements are referred to by commonreference numerals. In order to better appreciate the advantages andobjects of the present disclosure, reference should be made to theaccompanying drawings that illustrate the embodiment(s). The drawings,however, depict the embodiment(s) of the disclosure, and should not betaken as limiting its scope. The embodiment(s) of the disclosure will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings in which:

FIG. 1A illustrates a schematic diagram of the access catheter device inaccordance with embodiments of the present disclosure.

FIG. 1B illustrates a cross-sectional view of the access catheter deviceof FIG. 1A in accordance with embodiments of the present disclosure.

FIG. 1C illustrates a second cross-sectional view of the access catheterdevice of FIGS. 1A and 1B in accordance with embodiments of the presentdisclosure.

FIG. 2A illustrates an embodiment of an access catheter device featuringan inflatable elastomeric balloon in a first state in accordance withsome embodiments of the present disclosure.

FIG. 2B illustrates an embodiment of an access catheter device featuringan inflatable elastomeric balloon of FIG. 2A in a second state inaccordance with some embodiments of the present disclosure.

FIG. 3A illustrates an embodiment of an access/guide catheter devicefeaturing a compressible-expandable offset non-occlusive structuralelement/member in a first state in accordance with some embodiments ofthe present disclosure.

FIG. 3B illustrates an embodiment of an access/guide catheter devicefeaturing the compressible-expandable offset non-occlusive structuralelement/member of FIG. 3A in a second state in accordance with someembodiments of the present disclosure.

FIG. 4A illustrates an embodiment of an access catheter device featuringinflatable elastomeric double-balloons in a first state in accordancewith some embodiments of the present disclosure.

FIG. 4B illustrates an embodiment of an access catheter device featuringinflatable elastomeric double-balloons of FIG. 4A in a second state inaccordance with some embodiments of the present disclosure.

FIG. 5A illustrates an embodiment of an access catheter device featuringtwo serially placed compressible-expandable non-occlusive wire meshsupport structures in a first state in accordance with some embodimentsof the present disclosure.

FIG. 5B illustrates an embodiment of an access catheter device featuringtwo serially placed compressible-expandable non-occlusive wire meshsupport structures of FIG. 5A in a second state in accordance with someembodiments of the present disclosure.

FIG. 6A illustrates an embodiment of a hybrid-sized catheter devicefeaturing an inflatable elastomeric balloon in a first state inaccordance with some embodiments of the present disclosure.

FIG. 6B illustrates an embodiment of a hybrid-sized catheter devicefeaturing an inflatable elastomeric balloon of FIG. 6A in a second statein accordance with some embodiments of the present disclosure.

FIG. 7A illustrates an embodiment of a hybrid-sized catheter devicefeaturing a compressible-expandable non-occlusive wire mesh in firststate in accordance with some embodiments of the present disclosure.

FIG. 7B illustrates an embodiment of a hybrid-sized catheter devicefeaturing a compressible-expandable non-occlusive wire mesh of FIG. 7Ain a second state in accordance with some embodiments of the presentdisclosure.

FIG. 8A illustrates a first step in a sequence of process steps enabledby an embodiment of the access catheter device residing in a cerebralvein of interest to mediate transvascular access to tissue/media in theintracranial vault in accordance with some embodiments of the presentdisclosure.

FIG. 8B illustrates a second step in a sequence of process steps enabledby an embodiment of the access catheter device residing in a cerebralvein of interest to mediate transvascular access to tissue/media in theintracranial vault in accordance with some embodiments of the presentdisclosure.

FIG. 8C illustrates a third step in a sequence of process steps enabledby an embodiment of the access catheter device residing in a cerebralvein of interest to mediate transvascular access to tissue/media in theintracranial vault in accordance with some embodiments of the presentdisclosure.

FIG. 8D illustrates a fourth step in a sequence of process steps enabledby an embodiment of the access catheter device residing in a cerebralvein of interest to mediate transvascular access to tissue/media in theintracranial vault in accordance with some embodiments of the presentdisclosure.

FIG. 8E illustrates a fifth step in a sequence of process steps enabledby an embodiment of the access catheter device residing in a cerebralvein of interest to mediate transvascular access to tissue/media in theintracranial vault in accordance with some embodiments of the presentdisclosure.

FIG. 9A illustrates a first step in a sequence of process steps enabledby embodiments of the access catheter to provide post-proceduralhemostasis at the transvascular puncture site in accordance with someembodiments of the present disclosure.

FIG. 9B illustrates a second step in a sequence of process steps enabledby embodiments of the access catheter to provide post-proceduralhemostasis at the transvascular puncture site in accordance with someembodiments of the present disclosure.

FIG. 9C illustrates a third step in a sequence of process steps enabledby embodiments of the access catheter to provide post-proceduralhemostasis at the transvascular puncture site in accordance with someembodiments of the present disclosure.

FIG. 9D illustrate a fourth step in a sequence of process steps enabledby embodiments of the access catheter to provide post-proceduralhemostasis at the transvascular puncture site in accordance with someembodiments of the present disclosure.

FIG. 10 illustrates an embodiment of the catheter shaft featuringdiscreet segments of alternating reinforcement members along itslongitudinal extent in accordance with some embodiments of the presentdisclosure.

FIG. 11A illustrates an embodiment of the steerable catheter inaccordance with some embodiments of the present disclosure.

FIG. 11B illustrates a cross-sectional view of the steerable catheter ofFIG. 11A in accordance with some embodiments of the present disclosure.

FIG. 12 illustrates a access catheter device mediating extravascularnavigation with a transvascularly-introduced steerable catheter inaccordance with some embodiments of the present disclosure.

FIG. 13 illustrates an embodiment of the transvascularly-introducedsteerable catheter in accordance with some embodiments of the presentdisclosure.

FIG. 14 illustrates a process and an embodiment of the access catheterdevice mediating extravascular navigation in accordance with someembodiments of the present disclosure.

FIG. 15 illustrates a process and embodiment of an access catheterdevice mediating extravascular navigation with atransvascularly-introduced steerable catheter deploying an embodiment ofa highly compressible, shape memory planar electrocorticographyimplantable array in accordance with some embodiments of the presentdisclosure.

FIG. 16 illustrates a process and embodiment of an access catheterdevice mediating extravascular navigation with atransvascularly-introduced steerable catheter extravascularly deployingan embodiment of a highly compressible and micro- or self-actuatingplanar electrocorticography implantable array in accordance with someembodiments of the present disclosure.

FIG. 17 illustrates a process and embodiment of an access catheterdevice mediating extravascular navigation with atransvascularly-introduced steerable catheter deploying an embodiment ofa highly compressible and self-expanding conformable, planarmicroelectrocorticography implantable array in accordance with someembodiments of the present disclosure.

FIG. 18A illustrates first view of an embodiment of the hybrid-sizedcatheter device residing in a deep cerebral vein transvenouslydelivering a submillimeter, wireless (i.e., energy harvesting, nearfield radiofrequency, etc.) deep brain stimulator implant in accordancewith some embodiments of the present disclosure.

FIG. 18B illustrates second view of an embodiment of the hybrid-sizedcatheter device residing in a deep cerebral vein transvenouslydelivering a submillimeter, wireless (i.e., energy harvesting, nearfield radiofrequency, etc.) deep brain stimulator implant of FIG. 18A inaccordance with some embodiments of the present disclosure.

DETAILED DESCRIPTION

The present disclosure describes a system in which a guide/accesscatheter provides an endovascular conduit for co-axial catheter systemsand transcatheter instrumentation to transvascularly access the subduralspace, subarachnoid space, and the brain parenchyma—for targeted devicedelivery or implantation and/or tissue/media insertion/collectionwithout the needs for burr holes or craniotomy. Various novelneuroendovascular transvenous access/guide catheter designs and avariety of clinical applications that the catheter(s) would enable aredescribed herein, such as for the diagnosis and treatment of seizuredisorder, pathologic brain tissue (e.g., cancer, etc.), psychiatricdisease—cognitive/motor impairment, and movement disorder.

FIG. 1A-C illustrates a schematic diagram of the access catheter devicecomprising tubular structures featuring proximal and distal endsoperably connected through lumen(s), cut-away views of various layersand inner components/features, and cross-section views of innercomponents/features. In particular, FIG. 1A illustrates a schematicdiagram of the access catheter device, FIG. 1B illustrates across-sectional view of the access catheter device of FIG. 1A, and FIG.1C illustrates a second cross-sectional view of the access catheterdevice of FIGS. 1A and 1B.

The access catheter includes catheter shaft 101, a main central lumen102, lateral wall working exit lumen port 103, a distal end working exitlumen port 104, a segregated balloon inflation lumen 105, inflationports 106, balloon inflation ports 107, main ports 108, salineirrigation/infusion ports 109, braided reinforcement 110, coiledreinforcement 111, outer jacket of the catheter shaft 112, an innerliner 113, a reflowed/heat shrunk tapered tip 114, a selective deflectoror luminal molding 115 with an angle of luminal molding 116, and aselective passageway 117.

The access catheter 101 may be configured for performing extravascularprocedures in the brain. The access catheter 101 may include anelongate, flexible tubular body, and have a proximal end spaced apartfrom a distal end and at least one lumen extending axially therethrough. The lateral wall working exit lumen port 103 or side exit portmay be positioned along a surface of the elongate, flexible tubularbody. The distal end working exit lumen port 104 may be positionedapproximate the distal end of the flexible tubular body and incommunication with the lumen. In some embodiments, the lateral wallworking exit lumen port 103 may be in communication with the lumen 102.

Embodiments of the present disclosure include a catheter shaft featuringa proximal main port 108 on its hub for co-axially introducing cathetersand related instrumentation operably connected to a central lumen, aproximal saline infusion port 109 operably connected to the centrallumen 102, and a proximal balloon inflation port 107 operably connectedto a balloon inflation lumen 105 and inflation hole(s). The proximal endof the catheter device and its central lumen 102 are operably connectedto lateral wall 103 and distal end 104 working exit lumen ports. Aninternal molding 115 can serve as a size-limiting selective passagewayfor co-axial catheter-related instrumentation to facilitate deploymentfrom either the lateral wall working exit lumen port 103 or the distalend working exit lumen port 104. The catheter device throughout itslongitudinal extent may feature discrete segments that can have eitherbraided 110 or coiled 111 reinforcement materials or a combinationthereof, and a distal reflowed atraumatic tapered tip 114 withoutreinforcement materials in accordance with an embodiment of the presentdisclosure.

A selective deflector 115 may be positioned within the lumen 102. Theselective deflector 115 may be configured to deflect a procedurecatheter having a diameter greater than a preset threshold out throughthe side exit port 103, and be further configured to permit a guidecatheter having a diameter of less than the preset threshold to passdistally beyond the selective deflector and out through the distal endport 104 via the selective passageway 117. In some embodiments, theselective deflector 115 includes an inclined barrier positioned withinand partially occluding the lumen. The inclined barrier may include anaperture that has an aperture diameter less than a side exit portdiameter of the side exit port. The angle of inclination of the inclinedbarrier or angle of luminal molding 116 is illustrated in FIG. 1C.Possible range of angles for the angle of luminal molding 116 include arange between 15°-60° from the horizontal plane of the catheter shaft.The embodiments described herein may include a selective deflector 115having a luminal molding(s) forming a spherical or oblong shape withinthe inner lumen of the guide/access catheter. The utility of the luminalmoldings is to function as a both rail and a size-limiting selectivepassageway for co-axial catheters and instruments. The luminal moldingscan function as a rail for the larger diameter catheters (>0.90 mm) andpenetrators co-axially advanced and introduced through the lateral wallor offset working exit lumen port. The luminal moldings can function asa selective passage of smaller diameter instruments (<0.87 mm), such asmicrocatheters and guidewires, co-axially advanced through to the distalend working exit lumen port beyond the lateral wall working exit lumenport. The passage of smaller bore catheters or microcatheters exitingthe distal end of the catheter device can function to facilitateatraumatic distal navigation through tortuous cerebral venous anatomy.

The offset or lateral wall working lumen exit port 103 may be configuredfor selective catheter and transcatheter device or instrumentationdeployment or delivery. An internal set of leaflets or moldings 116constructed from semi-compliant materials (polymeric, laser-cut metal,or alloy materials) located within the main central lumen 102 of theguide/access catheter having an angle between 10-60 degrees relative tothe longitudinal axis of the tubular catheter shaft may function as arail to selectively guide wider diameter (>0.90 mm) co-axial cathetersand instruments with advanced functionality elements through the offsetor lateral wall working exit lumen port. Advanced functionality elementsmay include, but are not limited to flexible needles, biopsy devices,single or multi-mode optical fiber systems, piezoelectric transducers,complementary mixed-oxide sensors, electrodes or compressible-expandableelectrode arrays with stimulating or recording capabilities, drugdelivery apparatuses/devices, vascular defect repair materials and thelike.

The segregated balloon inflation lumen 105, inflation ports 106, ballooninflation ports 107, main ports 108, saline irrigation/infusion ports109, and the like, may be configured to allow for the separate controlvia selective inflation or deflation of one or more balloons orexpansion or compression of related lateral expandable support elementsvia welded pull-wires ranging between 0.20-0.35 mm in diameter,positioned eccentrically along or within the main central lumen of theaccess catheter. The segregated balloon inflation lumen 105 is locatedeccentrically within the main catheter shaft along its longitudinalextent. The segmented balloon inflation lumen 105 may be connected toits own proximal inflation port 107 and/or a saline-filled syringe orwire pulley system. These allow for independent inflation and/ordeflation of balloons or compression and/or expansion of wire mesh cageelements.

Embodiments disclosed herein relate to a catheter device comprising atubular shaft with a central lumen having an inner diameter, proximalend opening(s) and distal openings. The device may include a selectivedeflector that selectively facilitates the passage or deployment ofcatheters, microcatheters, guidewires, transcatheter devices, tools,instrumentation, or implants—Further, the access catheter device mayhave a proximal opening or port operably connected through a centrallumen of a tubular shaft to a lateral wall opening or offset workingexit lumen port and to a distal end opening or exit port through aselective deflector.

In some embodiments, the disclosed catheter device features a singlecircumferential extra-axial compliant member located distally on asteeply tapered end of the catheter shaft, and a lateral wall workingexit lumen port that is located between about 1 to 20 mm proximal to thedistal compliant member located on the distal tapered end of theendovascular catheter shaft. The distal compliant member may be anelastomeric balloon or a compressible/expandable wire mesh. The lateralwall working lumen exit port may be located on the catheter shaftbetween about 1 to 20 mm from its distal end and be configured toselectively deploy a coaxially-introduced catheter with or withoutadvanced functionality or unique features from its working exit lumenport(s), as well as transcatheter deliverable instruments or devices.Advantageously, a steeply tapered end may be used to facilitate accessto and anchoring within a tapering vein, such as the Great Vein ofGalen, the internal cerebral veins, or the basal vein.

In each embodiment, there is a selective passageway for a co-axiallyintroduced flexible needle, guidewire, dilator, catheter each providingselective passageway for transvascular catheter and/or transcatheterinstrument access to the subdural or subarachnoid space or brainparenchyma for the diagnosis and treatment of seizure disorder,pathologic brain tissue, psychiatric disease, motor impairment, andmovement disorder.

Optionally, the catheters 101 may have outer diameter between about1.3-2.2 mm. Optionally, the working lumen exit port comprises a diameterbetween about 0.4-1.95 mm. Optionally, the balloon(s) or expandable meshbonded to the catheter shaft have/has an outer diameter between about0.8-5 mm. Optionally, the catheter with advanced functionality comprisesan outer diameter between about 0.3 mm to 1.95 mm and an inner diameterbetween about 0.3 mm to 1.92 mm.

The access catheter device 101 can have an outer jacket 112 comprised ofa single or multiple durometer thermoplastic polymeric or copolymericmaterial (e.g., polyamide, polyether, polyurethane, polyimide, etc.).The longitudinal segments of the multi-durometer catheter can vary itsstiffness by the relative ratio of co-polymer blocks (e.g., Pebax:polyamide (stiff) versus polyether (soft), etc.). The ratio of thecopolymer block composition of the outer jacket 112 at a proximalsegment of the catheter shaft can have stiffer properties (i.e., higherdurometer) compared to catheter jacket segments located more distallythat can have more flexibility (i.e., lower durometer).

Alternatively or in conjunction, the access catheter device 101 can havereinforcing members, such as braided reinforcements 110 or coiledreinforcements 111 such as wires/polymers/alloys or laser-cut metalhypo-tube constructs, arranged variably in segments along thelongitudinal extent of the catheter shaft. The material of thesereinforcing members can be stainless steel, tungsten, nitinol, liquidcrystal polymer, or laser-etched metal (e.g., stainless steel, nitinol,etc.) hypo-tubes. The reinforcing members including the braidedreinforcements 110 and/or coiled reinforcements 111 can be embeddedbetween outer and inner polymeric layers referred to as outer jacket andinner lining, respectively, circumferentially arranged around thecatheter central lumen(s). Braided reinforcement 110 patterns can use,for example, sixteen wires or threads arranged in a regular braidpattern (one-under-two, over two) or diamond braid pattern(two-under-two, over two) or eight wires or threads in half-load diamondbraid pattern (one-under-one, over one).

An alternative or combination reinforcement pattern may include coiledreinforcements 111 such as variable pitch coiling. An alternative orcombination reinforcement pattern may include laser-cut metalhypotube(s) (e.g., stainless steel or nitinol). The reinforcing lasercut metal hypotube can have variable stiffness or flexibility propertiesalong discrete longitudinally arranged structural regions, and theseproperties can depend on the pitch or frequency of the laser-etchedperforations (e.g., pitch: 0.006-0.015, respectively).

The braided reinforcements 110, coiled reinforcements 111, or laser-cuthypotube reinforcement members distributed along the longitudinal extentof the catheter device shaft can have variable weave density, pick perinch (PPI), or pitch along specific segments so as to vary relativestiffness (e.g., <250 PPI, <0.1 inch, or >0.006, respectively) orflexibility (e.g., >20 PPI, >0.005 inch, or <0.015, respectively).

Embodiments of the present disclosure include, the catheter shaft mayfeature a one or more of reinforcement materials (e.g., stainless steel,tungsten, nitinol, or liquid crystal polymer) or patterns, specificallybraided or coiled, and/or variable weave density or pitch as illustratedin FIG. 1B. In some embodiments, a longitudinal segment of the catheterproximal to the offset/lateral wall working exit lumen port may bereinforced with a braided 111 pattern of materials embedded betweenouter 115 and inner 117 lining to increase the tensile strength andtorque transmission of the catheter. Longitudinal segments residing atmajor flexures in the venous anatomy can be reinforced with coils toprovide the catheter shaft with flexibility and kink resistance at majorstress/flexure points. A longitudinal segment distal to theoffset/lateral wall working exit lumen port 103 can be reinforced withcoils 113 embedded between an outer jacket 115 and inner lining 117 tomaintain distal trackability and optimal navigability through the acuteangle bends of the cerebral vasculature. A distal segment can benon-reinforced with heat shrunk polymeric layers for an atraumatic tip.Not depicted here, embodiments of the catheter shaft may be comprised oflaser cut stainless steel or nitinol hypo-tube to confer a similarperformance profile of torque transmission, pushability, trackability,flexibility, and navigability for use in the cerebral venous system,subdural or subarachnoid spaces.

In some embodiments, the access catheter device 101 can have an innerliner 113 including a hydrophilic polymer (e.g., polytetrafluoroethylene(PTFE), fluorinated ethylene propylene (FEP), high density polyethylene)that is configured to confer lubriciousness and a low coefficient offriction.

The outer jacket 112 or inner liner 113 of the access catheter 101 maybe composed of the same or different polymeric materials and coated withhydrophilic materials. Discreet segments of the access catheter device101 residing at acute bends can preferably be comprised of coilreinforcement elements or high pitch laser etched metal hypotubereinforcement elements to optimize the kink or compression resistance ofthe catheter shaft, while at the same time retaining flexibility atknown major stress points of vascular tortuosity. Major stress points ofvascular tortuosity include, but are not limited to, the junction of thebrachiocephalic vein and internal jugular vein, the junction of theinternal jugular vein and the sigmoid sinus, and the junction of thetransverse sinus and superior sagittal sinus, which is also referred toas the torcular herophili. For example, in some embodiments, the distalend of the access catheter 101 shaft beyond the lateral wall workingexit lumen port 103 or side exit, may include a coil reinforced segmentfor added flexibility with retained trackability to optimize itsnavigability through tortuous vascular anatomy.

In some embodiments, the distal end of the catheter may be tapered. Forexample, the tapered profile or outer diameter range may be between 0.5mm to 1.5 mm and or at an angle between 5 to 30 degrees. The tapered tip114 may be heat shrunk. In some embodiments, at the most distal segmentof the catheter device 101 shaft beyond the distal coiled segment, theouter and inner lining can be heat shrunk to form a ‘reflowed’ tip 114without wire reinforcement, thereby conferring to the most distal end ofthe catheter device 101 a ‘soft’, atraumatic tip 114.

In some embodiments, the distal end of the catheter device 101 and itstip 114 will be tapered so as to minimize its leading profile. Thetapering of the tip 114 may also reduce discrepancies in size betweenthe tip 114 and coaxially telescoped guiding smaller diametermicrocatheters and microguidewires. This may allow for atraumaticnavigation of the catheter within the cerebral veins while minimizingthe risk of intimal dissection

Embodiments with the features described herein including, but notlimited to, the tapered tip 114, outer jacket 112, inner liner 113,coiled reinforcements 111, and braided reinforcements 110, may becombined, varied, and/or optimized, depending on the extracranial venousaccess site and the target intracranial vessel segment of interest, toprovide an optimal profile of tensile strength for pushability,torquability, and kink resistance, as well as enhanced flexibility andtrackability through the traversed length of the cerebral venous. It isenvisioned that different segments of the transvascular catheter device101 can be composed of the same or different polymer and reinforcementmaterial(s) as that used in other segments.

Methods and materials for manufacturing of catheters and cathetercomponents used in the access catheter such as access catheter 101 mayinclude the following steps. First, a thin layer of polymer material(e.g., polytetrafluoroethylene (PTFE) or polyimide (PI)) can be extrudedthrough a die or dip coated through a mandrel to achieve a pre-specifiedcatheter inner profile (i.e., inner lining of the catheter lumen(s)).Second, coil, braid, or laser-cut metal hypotube reinforcementelement(s), which are independently assembled/manufactured, can beplaced over the polymer liner material. In a third step, a thermoplasticelastomer (TPE), such as polyether block amide, can then be heated andextruded through a die to achieve an optimal catheter outer profile anddurometer, and placed over the reinforcement braid/coil/hypotube andinner liner. In a fourth step, at a desired temperature and temperaturechange, the assembled reinforcement material, inner liner and jacketpolymers will interfuse, embedding the reinforcement elements within thepolymer layers and together forming a catheter shaft. In a fifth step,the outer jacket may be coated with additional hydrophilic orhydrophobic coating. In a sixth step, balloons can be fabricated byexpanding compatible materials (balloon blowing) within a mold for adesired shape and compliance. In a seventh step, the balloon stems canbe thermally or laser bonded to the catheter shaft at a desired locationon the catheter shaft. In an eight step, the catheter central lumen canbe fitted with a segregated lumen or lumens. In a ninth step asegregated lumen can serve as a balloon inflation lumen. In a tenthstep, the segregated lumen of the ninth step can be integrated with astainless steel wire laser bonded to the catheter tip to provide asteering capability. In an eleventh step, exposed compliant wire meshstructures can be integrated with the wire reinforcement embedded in thecatheter shaft or bonded to a pull wire. In a twelfth step, a segregatedlumen can house a single mode fiber, multimode fiber, a piezoelectrictransducer, or a complementary metal-oxide semiconductor.

Embodiments of the disclosed transvascular guide/access catheter device101 may include a multi-durometer material and/or variably reinforcedbraided/coiled/laser-etched construct between outer and inner polymericlinings comprising a tubular lumen(s), extra-axial expandable structuralmember(s)/element(s), a lateral wall working exit lumen port, and adistal end exit port. The embodied catheter device may be optimallyconfigured for use within intracranial cerebral veins and facilitateaccess to the subdural space, subarachnoid space, or brain parenchymavia the stepwise co-axial introduction of penetrating members, wires,catheters, or other related instrumentation and lateral wall workingexit lumen port deployment. Embodiments may include a catheter shaftreinforced by braided, coiled, or laser-etched constructs with variableweave density, picks per inch, or pitch along specific longitudinalsegments residing between outer and inner polymeric layers.

In some embodiments, the transvascular guide/access catheter device 101may include a tubular shaft, proximal port(s), a central lumen operablyconnected to a lateral wall working exit lumen port and a distal exitlumen port, and extra-axial offset expandable structuralmember(s)/element(s). In some embodiments, the access catheter device101 may have expandable compliant extra-axial member(s) locateddiametrically opposite to the lateral wall or offset working exit lumenport on the catheter shaft between about 1 to 20 millimeters (mm) fromthe distal end. The working lumen exit port can be located between about1 to 20 mm from the distal end of the catheter shaft diametricallyopposite to the offset compliant expandable structural member, and beconfigured to facilitate the selective deployment ofcoaxially-introduced catheters with or without advanced functionality orunique features, as well as transcatheter deliverable instruments ordevices, from its working exit lumen port(s).

In some embodiments (such as those illustrated in FIGS. 2A-3B) an accesscatheter, such as one analogous to that illustrated in FIGS. 1A-1C, mayinclude a laterally expandable support carried by the elongate, flexibletubular body which is positioned on an opposite side of the tubular bodyfrom the side exit port. Examples of laterally expanding supportsinclude inflatable balloons, laterally deflatable struts, and the like.

FIG. 2A-B illustrates an embodiment of an access catheter devicefeaturing an inflatable elastomeric balloon located diametricallyopposite to the lateral wall working exit lumen port in accordance withan embodiment of the present disclosure. In particular, FIG. 2Aillustrates an embodiment of an access catheter device featuring aninflatable elastomeric balloon in a first state and FIG. 2B illustratesan embodiment of an access catheter device featuring an inflatableelastomeric balloon of FIG. 2A in a second state.

The access catheter device includes a main central lumen 201 with alateral wall working exit lumen port 202, and a distal end working exitlumen port 203. The catheter may have a reflowed or heat shrunk taperedtip 204, luminal molding 205. The access catheter may also include aselective passageway 206, segregated balloon inflation lumen 207, aballoon inflation port 208, and a compliant elastomeric balloon 209 thatis capable of being deflated and/or inflated. A microcatheter 210 andmicroguidewire 211 may be contained within the assembly. In someembodiments, the access catheter device may be positioned within thecerebral vein 212.

The complaint elastomeric balloon 209 is illustrated in a deflated statein FIG. 2A and in an inflated state in FIG. 2B. The transvascular accesscatheter device illustrated in FIGS. 2A and 2B can includethermally-bonded compliant elastomeric balloon(s) 209 or an expandablenon-occlusive mesh integrated onto the catheter shaft reinforcementmaterial layer (see FIGS. 3A-3B). These expandable members can bemounted extra-axially opposite to the offset of lateral wall workingexit lumen port 202. In some embodiments, these compliant structurescan, once expanded, position the lateral wall or exit port 202 to theendoluminal surface, as well as provide support and stability to thetransvascular catheter system by buffering the back propagation offorward insertion forces as transcatheter tools, devices, or instrumentsare advanced through the subdural space, subarachnoid space, or brainparenchyma.

In some embodiments, the transvascular guide/access catheter device mayhave two lumens: (1) one central lumen 201 with a large inner diameterto wall thickness ratio for co-axial catheter and catheter relatedtools/instruments (e.g., guidewires, needles, etc.) and 2) a secondsmall diameter segregated lumen, such as a balloon inflation lumen 207.The balloon inflation lumen 207 can operably connect to a ballooninflation syringe via the balloon inflation port 208 attached to theproximal end of the catheter and terminate in a compliant or anultra-compliant elastomeric balloon 209 thermally bonded to the cathetershaft.

In some embodiments, the transvascular guide/access catheter device canhave a single offset balloon member 209 located more distally along thecatheter shaft diametrically opposite to a lateral wall or offsetworking exit lumen port 202. The balloon inflation lumen 207 operablyconnects a proximal port and distal balloon inflation holes, where theballoon inflation lumen may terminate. The offset balloon 209 can beexpanded with media (e.g., saline, contrast, etc.) and position andanchor the offset or lateral wall working lumen exit port 202 within acerebral vein.

In one embodiment, offset compliant or ultra-compliant balloon(s) 209are bonded to the endovascular catheter shaft opposite a lateral wallworking lumen exit port located distally on the endovascular cathetershaft. Associated with the offset balloon 209 can be a method toapposition the lateral wall working exit lumen port with the endoluminalsurface of the cerebral vein when the balloon is inflated, such that thelateral wall working exit lumen port is positioned and/or effaces in aspecific orientation against the luminal surface of vein prior tocreating a venous access site. In some embodiments, the endovascularaccess or guide catheter can have an outer diameter ranging between3.9-6.6 French (1.3-2.2 mm). The choice of compliant structure may be anelastomeric balloon material (e.g., polyurethane, silicon, chlonopreneetc.) or a compressible-expandable structural mesh element/member. Inits expanded state, the compliant structure(s) function(s) to negate: 1)the radial forces exerted on the endoluminal aspect of the vein, and 2)the backpropagation of forward insertion forces during transvascularpenetration and/or catheter advancement through intracranial spaces,tissues, or media. One function of an expandable balloonstructure/member featured on or introduced via the proposed access/guideendovascular catheter is to tamponade the venous access sitepost-procedurally to provide hemostasis.

FIG. 3A-B illustrates an embodiment of an access/guide catheter devicefeaturing a compressible-expandable offset non-occlusive structuralelement/member located diametrically opposite to the lateral wallworking exit lumen port in accordance with an embodiment of the presentdisclosure. In particular, FIG. 3A illustrates an embodiment of anaccess/guide catheter device featuring a compressible-expandable offsetnon-occlusive structural element/member in a first dormant state, andFIG. 3B illustrates an embodiment of an access/guide catheter devicefeaturing the compressible-expandable offset non-occlusive structuralelement/member of FIG. 3A in a second, expanded and deployed state.

As illustrated in FIGS. 3A and 3B, the access or guide catheter(analogous to those illustrated in FIGS. 1A-2B) may include a maincentral lumen 301, lateral wall working exit lumen port 302, distal endworking exit lumen port 303, a reflowed, or heat shrunk atraumatic tip304, luminal molding 305, and a selective passageway 306. A mesh sheath307 may be deployed and then removed from a target area. A complaintwire mesh and non-occlusive balloon may be compressed and/or expanded308. The access or guide catheter may be positioned within a cerebralvein 309.

In some embodiments, the transvascular guide/access catheter device canhave two lumens and a single offset expandable wire mesh structure 307.The offset expandable wire mesh structure 307 can be sheathed and/orcompressed via tension applied by a pull-wire, when maintaining alow-profile is desired. Unsheathing or removing tension from thepull-wire allows the compliant wire mesh structure 307 to achieve anexpanded state (shown in FIG. 3B). The lateral wall working lumen exitport 302 may be located on the catheter shaft between about 1 to 20 mmfrom its distal end, and be configured to selectively deploy acoaxially-introduced catheter with or without advanced functionality orunique features from its working exit lumen port(s), as well astranscatheter deliverable instruments or devices.

In some embodiments, the offset complaint, expandable wires or wire mesh307, which may or may not be polymer coated (e.g.,polytetrafluoroethylene, etc.), is bonded onto and/or woven into theendovascular catheter shaft opposite an oblong-shaped lateral wallworking exit lumen port located distally on the endovascular cathetershaft. Associated with the offset compliant wire mesh 307 may be amethod for juxtaposing the lateral wall working exit lumen port with theendoluminal surface of the cerebral vein when the compliant wire mesh307 is in its expanded state, such that the lateral wall working exitlumen port 302 effaces the endothelium of the vein prior to creating avenous access site. In some embodiments, an endovascular catheter thatcan have an outer diameter ranging between 3.9-6.6 French (1.3-2.2 mm)may be used. The choice of compliant wire structure may be nitinol,which may be polymer coated (e.g., with polytetrafluoroethylene, etc.)to minimize endothelial disruption or damage, and it functions to negateexcessive radial force exertion on the wall of the housing vein and/orthe backpropagation of forward insertion forces exerted during co-axialcatheter advancement through intracranial spaces or tissues.

FIG. 4A-B illustrates an embodiment of an access catheter devicefeaturing inflatable elastomeric double-balloons in-series flanking thelateral wall working exit lumen port 402 in accordance with anembodiment of the present disclosure. In particular, FIG. 4A illustratesan embodiment of an access catheter device featuring inflatableelastomeric double-balloons in a first dormant, non-deployed state andFIG. 4B illustrates an embodiment of an access catheter device featuringinflatable elastomeric double-balloons of FIG. 4A in a second, deployed,inflated state.

As depicted, the access catheter may include a first occlusion balloon407A and a second occlusion balloon 407B, where the first occlusionballoon 407A is positioned on the tubular body on a proximal side of theside exit port and the second occlusion balloon 407B is positioned onthe tubular body on a distal side of the side exit port. The accesscatheter may include a main central lumen 401, lateral wall working exitlumen port or side exit port 402, a distal end working exit lumen port403, a reflowed or heat shrunk tapered tip 404, luminal molding 405, aselective deflector 406, serial compliant elastomeric balloons 407A and407B, and a microcatheter 409, microguidewire 409. The access cathetermay be positioned within a cerebral vein 410.

In some embodiments, the transvascular guide/access catheter can have afirst balloon 407A and a second balloon 407B operably connected throughthe same inflation lumen in a dual lumen catheter design or throughdistinct inflation holes in single lumen catheter design. In someembodiments, the lateral wall working lumen exit port 402 may be locatedbetween about 1 to 20 mm from the distal end of the catheter shaftbetween the first balloon 407A and the second balloon 407B, wherein thefirst balloon 407A and the second balloon 407B may together be expanded,and a lateral wall working lumen exit port 402 located proximal to adistal balloon and/or distal to a proximal balloon and be configured toselectively deploy a coaxially-introduced catheter with or withoutadvanced functionality or unique features from its working exit lumenport(s), as well as transcatheter deliverable instruments or devices.

In some embodiments, the thermally bonded balloon(s) includes at leastone of polyurethane, chlonoprene, and silicone elastomeric materials.The two balloons 407A, 407B may be arranged in series flanking a lateralwall working lumen exit port 402 located on the lateral aspect of theendovascular catheter wall. Associated with the double balloon in seriesmay be a method for occluding physiologic drainage and retrograde,negative-pressure venous blood flow from entering the venous access siteand/or subdural/aubarachnoid space. In some embodiments, an endovascularguide/access catheter with an outer diameter ranging between 3.9-6.6French (1.3-2.2 mm) may be used. The choice of compliant structure maybe an elastomeric balloon material (e.g., polyurethane, silicon,chloroprene etc.) and it functions to negate prominent radial forceexerted on the wall of the housing vein and/or the backpropagation offorward insertion forces exerted during co-axial catheter advancementthrough intracranial spaces or tissues. Another function of the balloonfeature is to tamponade the venous access site after re-positioning toprovide post procedural hemostasis. The described design may be intendedto temporarily occlude the vein, anchor the catheter, and isolate theworking exit lumen port from venous blood flow.

FIG. 5A-B illustrates an embodiment of an access catheter devicefeaturing two serially placed compressible-expandable non-occlusive wiremesh support structures 508 flanking the lateral wall working exit lumenport in accordance with an embodiment of the present disclosure. Inparticular in FIG. 5A, the non-occlusive wire mesh support structures508 are compressed, and in FIG. 5B, the non-occlusive wire mesh supportstructures 508 are deployed or inflated.

As illustrated, in some embodiments, the access catheter device mayinclude a main central lumen 501 with a lateral wall working exit lumenport 502 (also known as a side exit port 502), a distal end working exitlumen port 503, an atraumatic tip 504, luminal molding 505 with aselective deflector 506, a mesh sheath 507, and compliant wire meshnon-occlusive balloons 508. The access catheter device may allow for amicrocatheter 509 to pass thru using a microguidewire 510. The accesscatheter device may be introduced into a cerebral vein 511.

In some embodiments, the wire mesh structure 508 includes cross-linkedthin nitinol wire, which may be polymer coated withpolytetrafluoroethylene and the like. The expandable wire mesh structurecan be sheathed with an outer tubular catheter and/or compressed viatension applied with a pull-wire when maintaining a low-profile isdesired, such as for endovascular navigation. Unsheathing or removingtension from the pull-wire allows the compliant wire mesh structure toachieve an expanded state.

A compliant wire mesh structure 508 may be expanded in lieu of a balloonstructure to provide an anchor for stability and/or buttress thebackpropagation of forward insertion forces exerted on the endovascularcatheter housing subsequently introduced and co-axially advancedsteerable catheters or transcatheter instrumentation.

Illustrated in FIGS. 5A and 5B, two expandable wired structures or wiremesh elements/structures 508 may be arranged in series flanking alateral wall working lumen exit port 502 located on the lateral aspectof the endovascular catheter wall. In some embodiments, an endovascularguide/access catheter with an outer diameter ranging between 3.9-6.6French (1.3-2.2 mm) may be used. The choice of compliant materials forthis expandable element/structure 508 may be a plurality of thin strandnitinol, which in turn may be coated with lubricous polymeric materials(e.g., polytetrafluoroethylene, etc.) so as to minimize endothelialdisruption or damage. The expandable wire structures or meshelements/structures 508 functions to anchor the guide/access catheter inplace and negate the prominent radial force exerted on the wall of thehousing vein and/or the backpropagation of forward insertion forcesexerted during co-axial catheter advancement through intracranial spacesor tissues.

FIGS. 6A-B illustrate an embodiment of a hybrid-sized catheter devicefeaturing an inflatable elastomeric balloon 607 distal to the lateralwall working exit lumen port in accordance with an embodiment of thepresent disclosure. The hybrid-sized catheter illustrated in FIGS. 6A-Bmay include a main central lumen 601, a lateral wall working exit lumenport 602, a distal end working exit lumen port 603, a tapered tip 604, aselective deflector 606 with luminal molding 605. The hybrid-sizedcatheter device may include compliant elastomeric balloons 607illustrated in a deflated state in FIG. 6A and an inflated state in FIG.6B. The balloon 607 may be configured to be inflated/deflated by way ofa segregated balloon inflation lumen. The hybrid-sized catheter devicemay be positioned within a cerebral vein 609.

As illustrated, the hybrid-sized distal balloon catheter may have a moreproximal offset or lateral wall working lumen exit port 602 emanatingfrom a wider diameter segment proximal to the proximal end of thecatheter shaft. In some embodiments, the described system may beintended for use in the deep cerebral veins where rapid tapering of veindiameters in rostral proximal draining segments have been reported onprior venography studies.

An associated microcatheter scaled end with an outer diameter betweenabout 1.2-3.2 French or 0.4-0.8 mm may be intended to access the narrow,rostral segments of deep cerebral veins atraumatically. The distalcompliant/ultra-compliant structural component such as balloon 607located on the distal microcatheter end may be inflated to temporarilyocclude physiologic venous drainage and/or anchor the catheter devicevia similar mechanisms of inflation used in conventional ballooncatheters described herein.

The wide diameter, more proximal portion of the catheter shaft mayfeature the offset or lateral wall working lumen exit port 602, whichmay be contiguous with the main lumen of the access catheter allowingfor 1.925 mm or less outer diameter range coaxial catheters and 18-34gauge sheathed flexible needles.

The disclosed design may be optimized for delivery of biopotentialsensing/stimulating/modulating devices into the subcortical nuclei orfor biopsy and ablation of deep-seated lesions. The described design maybe intended to temporally occlude the vein and isolate the working exitlumen port 602 from physiologic venous blood flow, anchor theendovascular catheter in place to stably guide the insertion ofpenetrating instruments into brain tissue or media, and providepost-procedural hemostasis by direct tamponade with inflation.

FIGS. 7A-B illustrate an embodiment of a hybrid-sized catheter devicefeaturing a compressible-expandable non-occlusive wire mesh supportdistal to the lateral wall working exit lumen port in accordance with anembodiment of the present disclosure. The hybrid-sized catheter deviceincludes a main central lumen 701 with a lateral wall working exit lumenport 702, distal end working exit lumen port 703, an atraumatic tip 704,and a selective deflector 706 formed of luminal molding 705. Thehybrid-sized catheter device may include a compliant and compressibleexpandable non-occlusive wire mesh support 708 which may be compressed(as illustrated in FIG. 7A) and/or expanded (as illustrated in FIG. 7B)by way of a mesh pullwire 707. The hybrid-sized catheter device may bepositioned within a cerebral vein 709.

The wire mesh support 708 may be formed of an expandable cross-linkednitinol and be located proximal the working lumen exit port of thehybrid catheter 703 emanating from the catheter shaft. The distalexpandable mesh component 708 located on the distal microcatheter endmay be intended to anchor the catheter in place during transvascularpuncture or insertion into brain tissue or media. The choice ofcompliant materials for this expandable element/structure 708 may be aplurality of thin strand nitinol, which in turn may be coated withlubricous polymeric materials (e.g., polytetrafluoroethylene, etc.) soas to minimize endothelial disruption or damage. The wide diameter, moreproximal portion of the catheter shaft may feature the offset or lateralwall working exit lumen port 702, which can be contiguous with the mainlumen of the access catheter allowing for 1.925 mm or less outerdiameter range coaxial catheters, penetrating members, or 18 gauge orsmaller flexible needles. The disclosed design may be optimized fordelivery of biopotential sensing/stimulating/modulating devices into thesubcortical nuclei or for biopsy and ablation of deep-seated lesions. Insome embodiments, the described system may be advantageously used in forlonger duration procedures where prolonged venous stasis or occlusionmay result in thrombus formation and/or venous hypertension,respectively.

FIG. 8A-E illustrate a sequence of process steps enabled by anembodiment of the access catheter device residing in a cerebral vein ofinterest to mediate transvascular access to tissue/media in theintracranial vault in accordance with an embodiment of the presentdisclosure.

The transvascular access catheter device embodiments described hereinare introduced from an extracranial vein and advancedintravenously/endovascularly for use in the intracranial cerebral venoussystem of a human or an animal to mediate access to extravascular spaceswithin the intracranial vault. As depicted in FIGS. 8-10, thetransvascular access catheter device in some embodiments can beintroduced at a convenient entry point from an extracranial vein (e.g.,subclavian vein, internal jugular vein, or femoral vein, etc.) through aguiding member (i.e., shuttle sheath).

The transvascular access catheter device can then be advanced to adesired intracranial location within a vein over telescoped co-axialguiding members emanating from its distal end exit port, which feature‘soft’ tip(s) and distal end radiopaque markers or fillers to aid invisualization. Once situated in a desired location within anintracranial vein, these telescoped guiding members may be removed. Asecond marker located adjacent to the lateral wall opening or offsetport may direct the user to rotationally adjust the transvascular accesscatheter device, such that a transcatheter penetrating device may bedeployed from the lateral wall opening or offset port over a selectivedeflecting member to puncture through the vein from its endoluminal sideand advanced transmurally in a trajectory that minimizes the potentialfor parenchymal damage. The created venous puncture site creates anentry point for guidewires, catheters, transcatheter instruments, andimplants to be introduced into the subdural or subarachnoid space ordirectly into the brain parenchyma.

A method for accessing a desired target intracranial location using atransvascular access catheter is depicted in FIGS. 8A-8E. In particularFIG. 8A illustrates cerebral venous access using a microguidewire andmicrocatheter coaxially advanced through the selective passageway anddeployed from the distal end working exit lumen port of the guide/accesscatheter. In a first step an endovascular access/guide catheter 801 maybe positioned within a cerebral vein 809 using a 0.014 or 0.018 inchmicroguidewire 808, co-axially introduced through a microcatheter 807,which may feature built-in pull-wires for steerable capabilities,together in a telescoped configuration. The endovascular access/guidecatheter 801 may include a side exit port or a lateral working lumenexit port 802 and a distal working lumen exit port 803. The endovascularaccess/guide catheter 801 may also include a selective deflector 805with luminal molding 806. Inflation or expansion of a compliantstructure (bonded balloon(s) or wire mesh structural member(s)) may beused to maintain the position of the lateral working exit lumen portnear/against the endoluminal surface of the vein at an entry point ofinterest. Additionally, inflation or expansion of the same compliantstructure(s) (e.g., balloon(s) or wire mesh structural member(s)) mayalso be used to provide a buffer against the back propagation of forwardinsertion forces.

FIG. 8B illustrates removal of the microcatheter and microguidewire fromguide/access catheter shaft lumen.

FIG. 8C illustrates co-axial introduction and deployment of a catheteror related instrumentation 811 through the lateral wall working exitlumen port 802. A retractable needle sheath 810 may facilitate needledelivery without damaging the inner liner as it is co-axially deliveredwithin the main catheter lumen through tortuous venous anatomy.

FIG. 8D illustrates transvenous and/or transdural puncture with apenetrating member across the vessel wall and into the brain parenchyma,subdural or subarachnoid space. In some embodiments, the vessel, and ifapplicable, the encasing dura, may be punctured with a penetratingcatheter or needle from the lateral wall working exit lumen port into aperivascular space.

FIG. 8E illustrates transvascular advancement and placement of aguidewire through the penetrating member into the brain parenchyma,subdural and/or subarachnoid space to guide subsequently introducedco-axial catheters or instrumentation. The guidewire may then beadvanced through the penetrating catheter or needle into a perivascularspace. The guidewire may then be retracted from the penetrating catheteror needle with the guidewire placed across the venous puncture site. Adilating catheter may be co-axially introduced via over the wiretechniques through a flexible, ‘soft’ tip catheter deployed from thelateral wall working lumen exit port across the venous puncture site andinto the subdural space. The subdural space may be navigated with aflexible, ‘soft’ tip catheter equipped with remote steerability control.

The methods described herein may be used for the transcatheterdeployment or delivery of a flexible brain biopsy-needle, a single or amulti-mode optical fiber for in situ imaging or a laser interstitialthermal therapy, respectively, a self-expandable electrode array, or animplantable nanofluidic apparatus. These transcatheter devices orimplants and the methods described herein may be used to diagnose,treat, or investigate intracranial tissue or media in an anatomicalboundary of interest located a distance (i.e., centimeters) from thetransvascular puncture site. Catheters or transcatheter instruments mayfacilitate implantation, anchoring, or retrieval of a device. During orafter the transvascular procedure, a balloon member located near, at, orbeyond the distal end of the catheter may either be deflated to allowfor rotational or axial repositioning of the endovascular catheterwithin the punctured vein. An elastomeric compliant or ultra-compliantballoon member may then be inflated over the transvascular puncture siteto seal or tamponade the vascular wall defect. In some instances, abioreabsorbable hemostatic material may be deployed over thetransvascular access site to achieve hemostasis.

As illustrated, the access catheter 801 may be positioned within thevein 808 using a guide catheter co-axially introduced over a guidewireand advanced through a selective passageway (<0.87 mm) and deployed fromthe distal end working exit lumen port 803 of the guide/access catheter801. The microcatheter and guidewire may be retracted from the centrallumen of the guide/access catheter 801. In some embodiments, a flexibleaccess needle may be co-axially introduced into the central lumen of theguide/access catheter. In a next step, a complaint structure (orstructures) is (are) expanded, positioning the lateral wall workinglumen exit port against the intended venous access site. In a next step,a flexible needle coated with polymeric material (e.g.,polytetrafluoroethylene, etc.) and/or sheathed in a retractable guard orcatheter may be selectively deployed out of the lateral wall workingexit lumen port 802. In a next step, the flexible needle penetratestransmurally across the vessel wall being reinforced with a stylet fortensile strength. After puncturing across the vein, the stylet iswithdrawn and a guidewire is advanced co-axially through theunreinforced flexible needle, such that it abuts the encasing durallayer. The flexible needle is withdrawn leaving the guidewire in placeacross the venous puncture site and abutting the encasing dura as aplaceholder.

FIG. 9A-D illustrate a sequence of process steps enabled by embodimentsof the access catheter to provide post-procedural hemostasis at thetransvascular puncture site in accordance with an embodiment of thepresent disclosure. As illustrated, the guide/access catheter 901 mayinclude a lateral wall working exit lumen port 902, a selectivedeflector 905 with luminal molding 906, a tapered tip 904, and a distalend working exit lumen port 903. As illustrated in FIGS. 9A-D, theaccess catheter 901 may be positioned within a cerebral vein 908.

In particular, FIG. 9A illustrates pulling back 909 the guide/accesscatheter 901 such that a balloon microcatheter 907 may be deployed fromthe distal end working exit lumen port 903 to tamponade the venouspuncture site for hemostasis.

FIG. 9B illustrates rotating the guide/access catheter such that theoffset balloon 910 may be positioned opposite to the lateral wallworking exit lumen port to tamponade the venous puncture site forhemostasis.

FIG. 9C illustrates axially repositioning the guide/access catheter suchthat one or more balloons positioned on the catheter shaft may beinflated to tamponade the venous puncture site for hemostasis. Thecatheter may include either an offset expandable structure 901, a distalexpandable structure 913, a proximal expandable structure 912A spacedapart from a distal expandable structure 912B, and a lateral wallworking lumen exit port 902 that may be positioned opposite to, proximalto, or between two expandable structure(s) 912A, 912A.

FIG. 9D illustrates the deployment of a bioresorbable hemostaticmaterial or mesh 913 from the guide/access catheter working exit lumenport(s) over the venous puncture site for hemostasis.

FIGS. 9A-9D illustrate a method for providing percutaneous transvascularaccess to a brain or subdural/subarachnoid space. In a first step, acatheter 901 is positioned within a cerebral vessel 908 adjacent to thebrain area of interest using a guidewire and/or microcatheter with orwithout steerable functionality. In some embodiments, the catheter 901may include a lumen, a single expandable element 907 or 910, or a firstexpandable structural element/member 912A and a second expandablestructural element/member 912B spaced apart from the first expandablestructural element(s)/member(s) 912A, and a lateral wall working lumenexit port 902 opposite to, between, or proximal to expandable structuralelement(s)/member(s).

Further, in some embodiments the first expandable structural element ormember, balloon 912A and the second balloon 912B may be connected via alumen, and the working lumen exit port 902 may be located between thefirst balloon 912A and the second balloon 912B. In some embodiments thefirst expandable structural member(s)/element(s) 912A and the secondexpandable structural element/member 912B may be sheathed or share acommon pullwire for compression into a low profile state, and lateralwall working lumen exit port 902 may be located between the firstballoon 912A and the second balloon 912B. Once the catheter 901 ispositioned, in a second step, the microcatheter and guidewire, ifutilized, may be retracted 909. In a next step, the compliantstructure(s)/element(s) on the catheter shaft 907, 910, 912A, 912B, 913may be expanded/inflated.

In a next step a flexible hollow needle or puncturing cannula sheathedin a protective tubular lumen may be deployed from the lateral wallworking exit lumen port 902. The flexible needle may be reinforced (notdepicted) with a stylet for tensile strength. A wire may be introducedthrough the access needle once the vascular wall is punctured andtraversed and the stylet removed. The wire or a catheter may be left inplace across the vascular wall as a placeholder to guide transvascularcatheter placement through the previously established venous puncturesite. A catheter with advanced functionality may be advanced over thewire through the guide/access catheter and then deployed into the brainarea of interest (parenchyma, subdural, or subarachnoid space) from thelateral wall working exit lumen port.

More particularly, a needle or a penetrating member may be advanced intoa peripheral vascular access site from a suitable vessel (e.g.,subclavian vein, internal jugular vein, brachial vein, femoral vein andthe like). In a next step, a wire may be advanced through the needle orpenetrating member. In a following step, a support sheath may beadvanced over the wire. In a next step, the guide/access catheter isadvanced through a support sheath. In a next step, a microcatheter maybe navigated distal to the intended transvascular puncture site fromwithin the endolumen of the vein over a microguidewire. Themicrocatheter can have steerable functionality. Then the guide/accesscatheter may be advanced over the telescopedmicroguidewire-microcatheter system to a suitable cerebral vein withinthe intracranial vault. Then the lateral wall working exit lumen port ofthe guide/access catheter may be rotationally positioned over theintended venous puncture site from within the endolumen of the vein.Compliant structural member(s)/element(s) of the guide/access catheterare inflated/expanded to optimally position the lateral wall workingexit lumen port and anchor the entire catheter system in place. Thedistal access microcatheter and microguidewire may then be removed fromthe guide/access catheter. A flexible or steerable needle/wire encasedin a second catheter or retractable protective sheath may then beintroduced through the lateral wall working exit lumen port of theguide/access catheter. In some embodiments, the flexible biopsy needlemay include an 18-34 Gauge needle.

The flexible and/or steerable needle may then, in an eleventh step, beunsheathed from its protective housing to mediate transvascular puncturefrom the endoluminal site and into the perivenular, subdural orsubarachnoid space. After the transvascular puncture, a guidewire may,in twelfth step, be introduced through the flexible needle andmaintained transvascularly, across the vessel wall, as a venous puncturesite placeholder prior to the removal of the flexible/steerable needle.In a thirteenth step, the needle may be withdrawn leaving only theguidewire in place with its proximal end emanating from the lateral wallworking exit lumen port and its distal end residing in brain parenchyma,subdural or subarachnoid space.

In a next step, an advanced functionality catheter with steerablecapabilities can be introduced over a wire into the subdural orsubarachnoid space over the cortical surface. In some embodiments, theadvanced functionality catheter can include flexible needles sheathed ina retractable guard, trocars, dilators, electrode embedded catheter,convection enhanced drug delivery catheters, imaging elements, devices,or apparatuses, or ablation elements, devices, or apparatuses and thelike. In a next step, the advanced functionality catheter may be used toperform intracranial transvascular direct brain access procedures (e.g.,biopsy, electrode placement, stimulator placement, tissue/media thermalenergy delivery, direct drug delivery, device placement). In someembodiments, the advanced functionality catheter may be a steerablecatheter equipped with electrodes or configured to deliver implantablerecording and/or stimulating electrodes or arrays.

In some embodiments, the advanced functionality catheter can be asteerable catheter configured to deploy a flexible biopsy needleequipped with or housing a single mode fiber for in situ imaging withoptical coherence tomography. In some embodiments, the advancedfunctionality catheter can be a microcatheter equipped with or housingeither a multimode fiber for thermally ablating tissues, media, and thelike within the intracranial vault. Advantageously, the multimode fibercan be configured for both laser interstitial thermal therapy andvolumetric photoacoustic imaging. In some embodiments, the catheter mayhouse or be equipped with a Fiber Bragg Grating Sensor to enable forceor temperature measurements.

In some embodiments, a steerable catheter can be configured to deploy amonopolar electrode or like device for thermally ablating tissues. Insome embodiments, a catheter housing or equipped with an opticalcoherence tomography configured single mode fiber, a photoacousticimaging configured mulitmode fiber, piezoelectric ultrasound imagetransducer, or computer metal-oxide semiconductor camera for real-timein situ imaging. In some embodiments, these imaging modalities may becombined with a thermal ablating component, functionality, or device,such as a multimode fiber, to enable real-time imaging of ablatedtissues. In some embodiments, the advanced functionality catheter may beconfigured with plurality of optical fibers to enable both real time insitu imaging, temperature monitoring, and ablation in alternating orsimultaneous fashion. In other embodiments, the advanced functionalitycatheter may include a micro-catheter configured with a plurality oflumens for convection enhanced direct drug delivery. In someembodiments, the advanced functionality catheter may be a steerablecatheter configured to deploy and implant biodegradable drug deliverynanofluidic devices or apparatuses (e.g., fabricated with materials,such as polydimethylsiloxane, silk, magnesium, etc.) withdose-controlled drug eluting capabilities.

In some embodiments, the expandable compliant structure(s) remainexpanded and serve to isolate the lateral wall working lumen exit port,preventing cerebral vein/sinus blood flow from entering into thesubdural/subarachnoid space. In some embodiments, the lateral wallworking exit lumen port is configured to be contiguous with thecatheter's main central lumen. In some embodiments, an internalstructure, such as a luminal molding, within the tubular lumen of thecatheter shaft serves to selectively guide larger co-axial catheters(>0.9 mm) through the lateral wall working exit lumen port. Inembodiments, the guide/access catheter may be advanced to a distallylocated cerebral vein within the intracranial vault and reside adistance from a brain parenchymal, subdural or subarachnoid area ofinterest.

In some embodiments, an advanced functionality catheter, such as asteerable catheter, may be co-axially introduced through the centrallumen over the placeholder guidewire, exit the lateral working exitlumen port, and advance across the vessel wall such that the steerablecatheter can enters the subdural or subarachnoid space where it may benavigated atraumatically to a remote site within the intracranial vault.

Further, the advanced functionality catheter may be removed/withdrawnfrom the embodied guide/access catheter. And the guide/access cathetermay be configured to deploy a bioresorbable hemostatic materialconfigured for endothelial repair of the venous puncture site. Acatheter-deliverable hemostatic biodegradable material may be introducedor implanted, such that it resides/overlays the transvascular puncturesite.

FIG. 10 illustrates an embodiment of the catheter shaft featuringdiscreet segments of alternating reinforcement members along itslongitudinal extent in accordance with an embodiment of the presentdisclosure. The access catheter is depicted as accessing distal cerebralveins/sinuses from a peripheral site, and transvascularly deploy asteerable catheter from its lateral working exit lumen port, which inturn enables subdural/subarachnoid navigation of the intracranial space.As illustrated in FIG. 10, the guide/access endovascular catheter shaftis variably reinforced with braids along longitudinal segments of thecerebral venous anatomy and reinforced with coils where flexures/bendsare present along tortuous segments of the cerebral venous anatomy.Distal to the lateral wall working exit lumen port, a segment of theguide/access catheter shaft may be coil reinforced to aid in theguide/access catheter's trackability and navigability through tortuouscerebral vessels. The most distal segment of the guide/access cathetermay be heat shrunk or reflowed for a soft, atraumatic tip. An embodimentof the steerable catheter may feature a steering collar proximal to alateral wall or distal end working exit lumen port laser-welded to apull wire residing within a segregated lumen of the guide/accesscatheter shaft.

Discrete longitudinal segments with alternating and variablereinforcement material to optimize the guide/access catheter'strackability through the tortuous cerebral venous system and theguide/access catheter's kink resistance at major stress points at acuteflexures are illustrated. The transvascularly deployed steerablecatheter is illustrated navigating the subdural/subarachnoid space andagile deployment of instruments, devices, cyto-activeagents/compounds/materials, or implants. Illustrated in FIG. 10 is theperipheral access site 1001 such as a subclavian vein, the internaljugular vein 1002, the sigmoid sinus 1003, transverse sinus 1004,torcula herophili 1005, and superior sagittal sinus 1006. The device mayinclude a variable pitch coiled reinforcement 1007, variable pick perinch braided reinforcement 1008, distal reflowed/heat shrunk tip 1009, alateral wall working exit lumen port 1010, and a co-axially offsetdeployed steerable catheter 1011.

FIG. 11 illustrates an embodiment of the steerable catheter with braidedreinforcement and a pull-wire laser welded to a steering collar fornavigating spaces within the intracranial vault in accordance with anembodiment of the present disclosure. Illustrated in FIG. 11A is asteerable catheter with braided reinforcement patterns and variable pickper inch 1101, and a cross section thereof in FIG. 11B. The steerablecatheter 1101 includes a polymeric liner 1102, braided reinforcementmaterial 1103, a pullwire 1104, steering collar 1105, an atraumatic tip1106, and an outer polymeric jacket 1107.

FIG. 12 illustrates a process and an embodiment of the access catheterdevice mediating extravascular navigation with atransvascularly-introduced steerable catheter featuring a lateral wallworking exit lumen port from which a deployed flexible biopsy needle anda through-the-needle deployed microcatheter housing one or more singleand/or multimode optical fibers for in situ imaging, sampling, and/orablating of tissue/media contents in accordance with an embodiment ofthe present disclosure.

Illustrated in FIG. 12 is an embodiment of an transvascular access/guideCatheter 1201 with an offset balloon built in accordance with thedescription herein. A steerable catheter is deployed into the subduralspace from the lateral wall exit lumen port of the lateral wall exitlumen port of the access/guide catheter 1202. A procedure catheterincluding a flexible biopsy needle 1203 may be precisely deployed fromthe steerable catheter's lateral wall working exit lumen port 1202.Further, a fiber optic equipped microcatheter 1204 may be deployedthrough the needle. The assembly may be used within the cerebral vein orsinus 1205 including, for example, the superior sagittal sinus.

In some embodiments, the procedure catheter may include at least one ofa flexible needle, a steerable needle, a retractable needle sheath, aretractable guard, a dilator, a steerable catheter, an imaging device,an ablation device, force sensors, temperature sensors, biopsy device, acompressible-expandable biopotential sensing or stimulation device orimplant, a convection-enhanced drug delivery microcatheter, or aninjectable drug eluting bioresorbable nanofluidic implant. An ablationdevice or imaging device may also include a microelectronic mechanicalsystem, optical technology, a flexible laser-cut hypotube, or co-axialactuating mechanical system. In some embodiments, thecompressible-expandable biopotential sensing or stimulation device orimplant may include a shape memory scaffold embedded with electrodesconfigured to transmit to a connector for recoding neurons, mappingcortical activity, stimulating neurons, or modulating cortical activity.

FIG. 13 illustrates an embodiment of the transvascularly-introducedsteerable catheter, a lateral wall working exit lumen port deployedflexible biopsy needle, and a through-the-needle deployed microcatheterhousing single and/or multimode optical fibers for in situ imaging,sampling, and/or ablating of tissue/media in accordance with anembodiment of the present disclosure.

Illustrated in FIG. 13 is a steerable catheter shaft 1301 with a lateralwall working exit lumen port 1302, a pullwire 1303, and a steeringcollar 1304. The steerable catheter includes an atraumatic tip 1305. Aflexible needle 1306 with needle sheath 1307 may be introduced via thesteerable catheter. Further, fiber optic equipped microcatheter 1308 maybe introduced via the steerable catheter. The fiber optic equippedmicrocatheter 1308 may be configured for locally sensing, stimulating,collecting, and/or ablating tissue and/or media.

FIG. 14 illustrates a process and an embodiment of the access catheterdevice mediating extravascular navigation with atransvascularly-introduced steerable catheter, a lateral wall workingexit lumen port deployed flexible biopsy needle, and an injectablenanofluidic device bioresorbable implant for sustained, dose-controlledrelease of cyto-active agents/compounds within the subarachnoid space inaccordance with an embodiment of the present disclosure.

Depicted in FIG. 14 is an embodiment of a transvascular access/guidecatheter with offset balloon 1401, and a steerable catheter 1402. Thesteerable catheter 1402 is deployed into the subdural space from thelateral wall exit lumen port of guide/access catheter. A flexible needle1403 may then be deployed from the steerable catheter's lateral wallworking exit lumen port. The flexible needle 1403 may be used to implanta sustained dose-controlled release bioresorbable nanofluidic capsule1404. Additionally, local antibody therapy dispersion may be dispensedfrom nanofluidic device channel 1405. The catheter assembly may bepositioned within the cerebral vein or sinus 1406, including, but notlimited to, the superior sagittal sinus.

FIGS. 15-17 illustrate processes and embodiments of the access catheterdevice used in connection with catheter-deliverablemicro-electrocorticography arrays. In some embodiments, the deploymentcatheter may be proximally retracted, trailing a multi-conductor leadtransvascularly to the percutaneous access site, then outside of thepatient, and then the puncture may be closed around the lead.

The lead may have a connector for removable connection to a controlsystem that may be in a housing attached to the patient such as bystraps or an adhesive in the case of an ambulatory patient, or a desktopunit as desired.

The ambulatory patient control may include a power supply, processor anda memory for retaining programmed operating parameters and/or storingsensed patient data. In some implementations the control may includesensing circuitry for sensing an electrical parameter in the brain andgenerating a responsive, therapeutic signal for delivery to the brainvia the electrode array. In some embodiments, the array may be anchoredwithin the vein and be powered or transmit wirelessly viamicroengineered coils or chips.

FIG. 15 illustrates a process and embodiment of an access catheterdevice mediating extravascular navigation with atransvascularly-introduced steerable catheter deploying an embodiment ofa highly compressible, shape memory planar electrocorticographyimplantable array in the subdural space over the cortical surface of thebrain optimally configured for modulating neuronal activity over afunctional neuroanatomical zone in accordance with an embodiment of thepresent disclosure.

As depicted, an embodiment of transvascular access/guide catheter withoffset balloon 1501 may be used for the deployment of aelectrocorticography array. The steerable catheter 1502 may be deployedinto the subdural space from the lateral wall exit lumen port ofguide/access catheter being retracted. The catheter may be configured todeliver a super-elastic shape memory thin film electrocorticographyarray 1503 connected to a wire bundle connector 1504. The wire bundle1504 may be encased in a shape memory hypo-tube 1505. The entireassembly may be positioned within the cerebral vein or sinus 1506 suchas the superior sagittal sinus. The embodiment illustrated in FIG. 15may be optimally configured for modulating neural activity over afunctional neuroanatomical zone.

FIG. 16 illustrates a process and embodiment of an access catheterdevice mediating extravascular navigation with atransvascularly-introduced steerable catheter extravascularly deployingan embodiment of a highly compressible and micro- or self-actuatingplanar electrocorticography implantable array in the subdural space overthe cortical surface of the brain optimally configured for mappingactivity over a large spatial extent and across distinct functionalneuroanatomical boundaries in accordance with an embodiment of thepresent disclosure.

As illustrated an embodiment of transvascular access/guide catheter withoffset balloon 1601 may be used. A steerable catheter 1602 may bedeployed into the subdural space from the lateral wall exit lumen portof guide/access catheter being retracted. The catheter may be configuredto deliver a super-elastic shape memory thin film electrocorticographyarray 1603 connected to a wire bundle connector 1604. The wire bundle1564 may be encased in a shape memory hypo-tube 1505. The entireassembly may be positioned within the cerebral vein or sinus 1606 suchas the superior sagittal sinus. The embodiment illustrated in FIG. 16may be optimally configured for mapping neural activity over a largespatial extent and across distinct functional neuroanatomicalboundaries.

FIG. 17 illustrates a process and embodiment of an access catheterdevice mediating extravascular navigation with atransvascularly-introduced steerable catheter deploying an embodiment ofa highly compressible and self-expanding conformable, planarmicroelectrocorticography implantable array in the subdural space overthe cortical surface of the brain optimally configured for direct, highresolution central neural interfacing in accordance with an embodimentof the present disclosure.

As illustrated in FIG. 17, a transvascular access/guide catheter withoffset balloon 1701 may be used to deliver a self-expanding meshelectrocorticography array 1703. A steerable catheter 1702 may bedeployed into the subdural space from the lateral wall exit lumen portof the guide/access catheter 1701 being retracted. Theelectrocorticography array 1703 may be connected by a wire bundleconnector 1704, where the wire bundles may be encased in a shape memoryhypo-tube 1705. The assembly may be positioned within the cerebral veinor sinus 1706, including for example, the superior sagittal sinus.

FIGS. 18A and 18B illustrate an embodiment of the hybrid-sized catheterdevice residing in a deep cerebral vein transvenously delivering asubmillimeter, wireless (i.e., energy harvesting, near fieldradiofrequency, etc.) deep brain stimulator implant through apenetrating member deployed from the lateral wall working exit lumenport directly into subcortical nuclei in accordance with an embodimentof the present disclosure.

Illustrated in FIGS. 18A and 18B is an embodiment of a transvascularhybrid-sized catheter with distal expandable non-occlusive mesh balloon1801. A steerable catheter 1802 may be deployed into the subdural spacefrom the lateral wall exit lumen port of guide/access catheter 1801being retracted. The catheter 1802 may be used to deliver a wirelesssubmillimeter deep brain stimulator 1803. The assembly may be positionedwithin the cerebral vein and sinus 1804, including for example, theinternal cerebral vein.

The embodiments, methods and transvascularly introduced cathetersdescribed herein may be steered or guided through the subdural space toremote sites located centimeters away from the transvascular puncturesite for precise and pre-specified delivery to target intracranialsites, tissues, or media representing a significant advancement overcurrent methods/systems. Increasing the weave density or picks per inchof the transvascularly introduced steerable catheter can improve itstrackability and navigability through the subdural/subarachnoid space.Steerable functionality may comprise pullwire(s) laser welded to asteering collar or a ferromagnetic tip deflectable via applied magneticfields. By increasing the number of pull-wires or the thickness of thepull-wires, enough tensile strength may conferred to the steerablecatheter enabling it to remain in a precise configuration at/near atarget site despite the introduction of catheters, instruments, or toolsthat can impose loading forces within the steerable catheter lumen.

The use of a balloon near the distal end of catheter wall and/oropposite the lateral wall working exit lumen port, or deployed from thedistal end working exit lumen port of the catheter, also provides amechanism for postprocedural hemostasis. In some embodiments, abioabsorbable hemostatic material includes least one of Poly (L)polymer, and Dextran-Sucrose-Sodium Citrate polymer may be used whenballoon inflation insufficiently provides hemostasis. In someembodiments, a catheter with advanced functionality includes at leastone of: a steerable catheter; a steerable needle; a flexible needlesheathed in a steerable catheter or a protective tubular member; acatheter housing fiber optic and related elements; a catheter with animaging or an ablative optical fiber; a catheter housing a complementarymetal-oxide semiconductor and related elements; a catheter designed todeliver and/or retrieve a biopotential sensing/stimulating/modulatingdevice; a drug delivery microcatheter for convection enhanced drugdelivery; or a catheter configured to deliver a nano/micro-fluidicapparatus.

Embodiments associated with the present disclosure may includeapproaches, techniques, and methods that reduce the invasiveness,collateral damage, and mis-targeting associated with conventionaltechniques for accessing brain and related intracranial tissue or mediafor the diagnosis and treatment of seizure disorder, brain cancer,infection, inflammation, degeneration, psychiatric disease, memory ormotor impairment, or movement disorder.

Embodiments of the present disclosure may include a method for providingtransvenous access to a brain. In some embodiments, a method forproviding transvascular access to a brain includes the steps of: 1)positioning a first guide/access catheter within a vessel via a guidingmechanism, such as a microcatheter and microguidewire enabling passivetraction or ferromagnetic distal tip structure enabling remoteelectromagnetic guidance, wherein the first catheter comprises a lumen,an extra-axial expandable structural member, and a lateral wall workingexit lumen port; 2) inflating balloon(s) or expanding a compliant meshstructure on the first catheter; 3) deploying a second catheter oradvanced function catheter (e.g., penetrating catheter or needlesheathing catheter) through the lateral wall of the working exit lumenport; 4) deploying and/or unsheathing the needle, puncturing across thevein, creating a venous puncture site, and advancing a second steerableor remotely guided catheter into a target area; 5) transcatheterdeployment of device(s) to either collect tissue, deliver drugs, implantdevices, record from neurons, modulate neuronal activity, or ablatetissue; 6) removing the second catheter, and deflating the balloon(s) orcompressing the expandable mesh of the first catheter; 7) repositioningthe first catheter such that at least one of the deflated balloonsoverlays the venous puncture site or inflating a balloon on or at thedistal end of a catheter; 8) inflating a balloon positioned over thetransvascular puncture site for direct tamponade; 8) evaluating ifhemostasis has been achieved by deflating the balloon(s); 9) deploying abiosynthetic, bioresorbable hemostatic material from an exit port overthe transvascular access site from a co-axial catheter emanating from anexit lumen port of the endovascular catheter in response to poorhemostastic control.

Optionally, the endovascular guide/access catheter has an outer diameterbetween about 1.3-2.2 mm (3.9 to 6.6 French). In some embodiments, theworking lumen exit port(s) can have a diameter between about 0.4-1.95mm. Optionally, the catheter may feature reinforced tubing with avariable weave density, picks per inch, or pitch between about0.005-0.1, 20-250, or 0.015-0.006, respectively, along specific segmentsof the catheter shaft. Optionally, the internal luminal moldings mayhave an angle from the horizontal plane between about 15-60 degrees.Optionally, expandable structure member(s) can have an outer diameterbetween about 0.8-5 mm. Optionally, the balloon(s) includes at least oneof polyurethane, chlonoprene, and silicone. Optionally, the expandablemesh structural member(s) can be a shape memory alloy/material (e.g.,Nitinol). Optionally, the expandable mesh structural member(s) can beconformally coated with parlyene, polyether-ketone, or polyurethane.

In some embodiments, the second catheter with advanced functionalitydeployed from the lateral wall lumen exit port includes at least one ofa preformed shape memory catheter, a steerable catheter or needle, aflexible needle sheathed in a steerable catheter, a catheter housing afiber optic imaging, sensing, or stimulating probe, a catheter encasingan ablative thermal therapy fiber optic probe, a transcatheter implantretrieval device, a drug delivery microcatheter, and a drug-elutingnanofluidic implant.

Optionally, the second catheter device with advanced functionality canhave an outer diameter between about 0.4-1.95 mm and an inner diameterbetween about 0.3-1.92 mm. Optionally, the second catheter may beco-axial to the first catheter. Optionally, the bioabsorbable materialfurther includes at least one of Poly (L) polymer, and Dextran-Sucrose-Sodium Citrate polymer.

Embodiments of the present disclosure are directed towards a device, andrelated systems and methods for transvascular access to the brain andmore particularly to catheter-based systems and methods useable fordirectly accessing tissue/media contents within the intracranial vault,local drug delivery, tissue biopsy, media sampling/collection,device/implant delivery, or energy delivery for imaging, sensing,stimulating, modulating, or ablating abnormal brain tissue and the likewithout burr holes or craniotomy. Brain tissue may include neurons,glia, or their constituent components, as well as benign or malignanttissue(s) that originate from the brain or spine, or from anexogenous/extracranial organ (metastatic lesion) source. Althoughembodiments of the present disclosure are discussed in relation toaccess to brain tissue, it is envisioned that the disclosed areas may bemodified for use with other areas.

In some embodiments, the expandable structural elements are configuredto have a diameter or radius in the range of approximately 0.5-6 mm. Insome embodiments, the working lumen exit port may have a diameterranging between 0.4-1.95 mm. In some embodiments, the catheter lumen 105may have a diameter of approximately 0.4-2.0 mm. In some embodiments, afirst, proximal expandable structure 101 and a second, distal expandablestructure 103 may be of the same diameter. In alternative embodiments,the first proximal expandable structure and the second, distalexpandable structure may have different sizes.

In some embodiments, the expandable structural elements may be composedof compliant or ultra-compliant material exerting less than 400 mm Hg ofpressure, which is below the radial force threshold associated with veinrupture or laceration of the vein (>600 mg Hg).

In some embodiments, the expandable element(s)/structure(s) may bespherical, toroidal, rectangular, cylindrical, or variable in shape.Further, expandable structures may be composed of silicone,polyurethane, chlonoprene, or cross-linked nitinol and the like.Spherical expandable element(s)/structure(s) are illustrated in someembodiments because this shape may have more predictable inflationparameters and may be more widely available or engineered. The cathetermay or may not feature spherical balloons.

In some embodiments, the expandable elements/structures (e.g.,elastomeric balloons or expandable nitinol 3D structure) in thedescribed system are configured to prevent vascular blood flow fromentering into the perivascular and subdural/subarachnoid space(s) oncetransvascular access is obtained.

Advantageously, positioning the lateral wall working lumen exit portbetween the two balloons may also temporarily occlude physiologicalvascular blood flow, as well as prevent retrograde negative-pressuregradient vascular blood flow from downstream nearby branchingtributaries or caudal channels from entering into theperivascular/subdural/subarachnoid space(s).

In some embodiments, the access/guide catheter discussed herein mayfeature only single expandable structural element/member distal to thelateral wall working exit lumen port, which may temporarily minimizeblood flow or occlude a draining vein upstream and distal to the lateralwall working exit lumen port.

In comparison to conventional systems mediating neuroendovascular accessand transcatheter instrumentation, the disclosed systems include alateral wall working lumen exit port configured proximal to, between, oropposite to compressible-expandable structural element(s)/member(s).Further, in comparison to conventional systems mediating transvascularaccess, the disclosed systems allow for neuroendovascular use and moreparticularly, distal venous access within the intracranial vault, aswell as allows for the co-axial introduction of penetrating instrumentsand/or additional catheters from the lateral wall working exit lumenport for transmural/transvascular, subdural/subarachnoid, brainparenchymal entry/access/navigation.

In some embodiments, the disclosed catheter device may act as a conduitfor co-axially-introduced catheters with or without advancedfunctionality, such as a flexible needle or needle sheathed in aprotective tubular housing unit or catheter, a fiber optic ablationmini-endoscope or catheter, an imaging probe or catheter, a pre-shapedor a steerable catheter for targeted deployment of an implantableelectrode array (such as a self-expanding, shape memory, or flexibleelectronic) or a catheter-deliverable micro/nano-fabricated device (suchas sustained release drug-eluting nanofluidic seed implant or wirelesssubmillimeter deep brain stimulator).

Advantageously, positioning the lateral wall working lumen exit portopposite to the complaint expandable balloon or mesh structures mayjuxtapose penetrating instruments or members deployed from the lateralwall working exit lumen port against the endoluminal surface of theintended venous puncture site to prevent the infiltration of vascularblood flow into the perivascular/subdural/subarachnoid space(s).

Advantageously, positioning the lateral wall working lumen exit portbetween the two balloons may also temporarily occlude physiologicalvascular blood flow, as well as prevent retrograde negative-pressuregradient vascular blood flow from downstream nearby branchingtributaries or caudal channels from entering into theperivascular/subdural/subarachnoid space(s).

In some embodiments, the access/guide catheter disclosed herein mayfeature only single expandable element/structure distal to the lateralwall working exit lumen port, which may temporarily minimize blood flowor occlude a draining vein upstream and distal to the lateral wallworking exit lumen port and allowing for a second catheter to beintroduced co-axially to mediate the transvascular puncture procedureand transvascular catheter or transcatheter device introduction.

In some embodiments, the guidewire may include a hydrophilic-coatedmetal guidewire having a 0.014 inch, 0.018 inch, or similar diameter anda variable length. For example, the variable length may be between 80 to300 cm. A guidewire introduced through a microcatheter configured toextend along the central lumen through to the distal exit port toposition the embodied transvascular guide/access catheter device(s).Alternatively or in conjunction, the catheter or microcatheter mayfeature steerable properties and external control actuators (e.g., wirepulley system or magnetically-guided catheter tips).

In some embodiments, including, but not limited to those illustrated inFIGS. 8, 10, 12, 14-18), the access/guide catheter accommodates a secondcatheter equipped or adapted with advanced-functionality (e.g., asteerable needle, a flexible needle sheathed in a steerable catheter,flexible needle or catheter with optical imaging, ablative, and/or atranscatheter deliverable detachable flexible electroceutical, drugdelivery microcatheter or fluidic chamber, etc.) to be deployed from itslateral wall working exit lumen port. The lateral wall working exitlumen port allows for the passage and deployment of catheters withadvanced-functionality or other related instrumentation across thevessel wall into an extravascular target tissue/space trajectory. Thewire deployed from the penetrating member can guide/specify thetransvascular target entry site aided by the anchoring placement of theguide/access catheter by expansion of compliant structuralelement(s)/member(s).

Further endothelial repair material may be deployed from a working exitlumen port to patch and/or repair the transvascular access site forhemostasis. In some embodiments, expandable structuralmember(s)/element(s) may be compliant or super-compliant (e.g.,polyurethane, chlonoprene, silicone, or nitinol mesh) so as to preventvessel rupture, laceration, or dissection on inflation. Inflatableballoons may be configured to prevent venous blood flow from enteringthe space occupied by the lateral wall working exit lumen port or thevenous puncture site.

In some embodiments compliant balloon catheter element(s)/member(s) maybe facilitate the transvenous access procedure by concealing orisolating the lateral wall working exit lumen port from venous bloodflow without occluding the vein entirely to allow needle or transvenouscatheter insertion. In some embodiments, in order to perform itsintended function the disclosed catheter would feature a smaller outerdiameter (e.g., less than 2.5 mm) for use in the cerebral veins. Balloonshape may vary, but it principally functions to minimize bloodinfiltration into the brain parenchyma, subdural or subarachnoid spacesfrom the transvascular puncture site. Any variety of shapes mayaccomplish this.

In some embodiments, the catheter may be configured to be straightwithout angulation or curvature. Such a catheter may be configured totaper over a variable length (e.g., 1-5 cm) and provide access indraining veins that would not accommodate a wider lumen catheter. Thetapered end would may feature a wire lumen to non-traumatically guidethe catheter to a deep cerebral or small diameter cortical drainingveins. Alternative steering mechanisms may be employed (e.g.,steerability via pull-wires or magnetic guidance). It provides theadvantage of a balloon occluding the cerebral vein distally withouthaving to access the entire vein with the large lumen end of thecatheter. It would in essence enable transvenous access with a largerlumen co-axial catheter to veins with a rapidly tapering diameter.

In some embodiments a catheter may include a distal compliant expandablewire mesh operably connected to pullwire housed in a segregated lumenfor transvenous access that is configured to anchor the site of thelateral wall working exit lumen port without occluding the vein entirelyso as to allow penetrating member and/or catheter deployment. In orderto perform its intended function the distal end of the proposed catheterwould feature a smaller outer diameter (e.g., less than 1.1 mm) for usein the deep cerebral veins.

In some embodiments, the torqueable catheter may include a tip that istorqueable via two wires flanking diametrically opposed ends of thecatheter lumen. The two wires may operate via a pulley system enablingproximal torque application for distal steerability.

In some embodiments the working lumen exit port supports theintroduction of a steerable catheter or sheathed flexible needle that isconfigured to reduce the required insertion force. Further the cathetermay be capable of dilating the transvenous access site and allowing forclose approximation of the distal end of the adapted-catheter withadvanced-functionality exiting the working lumen exit port, which inturn allows for transvenous cannulation beyond the peri-venular spaceand into the target tissue site or subdural/subarachnoid space. Theunsheathed flexible needle and housing catheter can then be completelyretracted from the perivascular space while affixing/approximating thedistal end of a co-axial catheter at the transluminal cannulation site.A catheter will protrude from the working lumen exit port to enabletransvenous access from an endovascular site whilst its distal end ispositioned near/into the perivascular/subdural/subarachnoid space.

In some embodiments, the transvenously affixed/abutted catheter mayallow for the introduction of a flexible biopsy needle, ablationcatheter with in situ imaging capabilities,chemotherapeutic/immunomodulatory drug delivery via catheter or implant,or insertion of a catheter deliverable recording/stimulating electrodelead or expandable cortical microelectrode array to be directlyintroduced to/over brain tissue and, in those instances where it isclinically indicated, later withdrawn.

Upon completion of the transvenous procedure the balloon may bedeflated, repositioned, and re-inflated, or in some cases abiodegradable material will be deployed to overlay the puncture site andprevent intraparenchymal hematoma formation by sealing the endoluminalvenous puncture site.

In some embodiments, the biodegradable biopolymer material may includeone or more of Poly (L) polymer, Dextran-Sucrose-Sodium Citrate polymer,and the like. The mesh may be square, oval, or cylindrically shaped. Insome embodiments the surface area of the nanofiber mesh may be largeenough to patch the venous entry site (e.g., 0.5 mm to 2 mm squared).

In some embodiments, the disclosed catheters and related components maybe sized appropriately to provide transvenous cannulation and/or access.In particular, in some embodiments the endovascular balloon catheter maybe scaled to between 2.4 French to 6 French (0.8-2.0 mm) size, dependingon the vein that is to be accessed. Additionally, coaxially introducedcatheters may feature a length at least 10 cm beyond the length of theendovascular balloon catheter and an outer diameter at least 0.003 inchsmaller than the endovascular balloon catheter working exit lumen portinner diameter.

In some embodiments, the disclosed flexible needle may be fabricated andinterspersed with flexible elements. A wire pulley system will enableits sheathing catheter to maneuver the needle in its intended incidentangle trajectory.

In some embodiments, the apparatus, methods, and systems associated withthe present disclosure may be used in connection with dynamic imagingtechniques and reliable fiducial markers located in proximity to thetissue of interest so as to better target the brain tissue of interest(e.g., the lesion or anatomical substrate of interest).

Additionally, specific anatomical locations, such as the posterior fossaand the presence of coagulopathic risk factors may discourage the use ofconventional methods such as open surgical and current stereotacticmethods for accessing brain tissue. A method for overcoming thesebarriers provides advantages to the healthcare system, such asimprovement in tissue diagnosis to tailor treatment and potentially curedisease, decreased length of hospital stay and complication rate, andincreased patient satisfaction.

In some embodiments, the catheter may be deployed by first usingstandard percutaneous central venous access via either the subclavianvein, femoral vein, or internal jugular vein. Then the 6 French accessballoon catheter may be advanced over microguidewire-microcathetersystem in telescoping coaxial configuration to a cerebral vein, such asthe Superior Sagittal Sinus. Further, the working lumen exit port sitemay be positioned over intended venous puncture site from within theendolumen of the vein. Then an imaging optical fiber, ultrasound, ormicrocamera probe equipped flexible needle may be advanced through theworking exit lumen port of the access catheter to the intended venouspuncture site from the endolumen of the vein over a microguidewire toenable in situ imaging. Then the extra-axial support structures may beexpanded to minimize venous physiologic drainage and backflow across thevenous puncture site. Then a flexible/steerable needle and/or cathetermay be equipped with an imaging fiber optic, ultrasound, or microcameraprobe may be advanced through the working lumen exit port. Next, aflexible/steerable needle may perform a transvenous puncture from anendoluminal site to the extravascular space. Next, a flexible needle andits corresponding sheathing catheter or guard may be removed whileretaining a guide wire in place to re-locate the puncture site. Next, asteerable catheter, which may feature an imaging fiber optic probe,ultrasound transducing, or video microcamera may be introduced over theguidewire into an extravascular space, after which the guidewire may beremoved.

If deployed within the subarachnoid space, the arachnoid trabeculae maybe mechanically sheared or ablated and/or the microvasculature insubarachnoid space where a medical device is to be deployed may becauterized. The catheter may be removed, such that a distinct devicedelivery catheter may be introduced. In next steps, a device may beintroduced through a steerable device delivery catheter. After thedevice is introduced it may be deployed and the steerable devicedelivery catheter may be removed.

In a next step, a hemostatic biodegradable mesh or stent may bedelivered over the venous puncture site if the balloon tamponade doesnot create hemostasis. The balloon catheter can then be deflated andremoved. In a last step a wire bundle configured to power, transmit toand/or receive signals from the electrode array may be subcutaneouslyattached to an implantable battery and/or transponder pack in thethorax.

Although particular embodiments of the present invention have been shownand described, it should be understood that the above discussion is notintended to limit the present invention to these embodiments. It will beobvious to those skilled in the art that various changes andmodifications may be made without departing from the spirit and scope ofthe present invention. Thus, the present invention is intended to coveralternatives, modifications, and equivalents that may fall within thespirit and scope of the present invention as defined by the claims.

We claim:
 1. An access catheter system for extravascular procedures in abrain, including an access catheter comprising: an elongate, flexibletubular body, having a proximal end, a distal end and at least one lumenextending axially there through; a side exit port positioned along theelongate, flexible tubular body, spaced proximally apart from the distalend and in communication with the lumen; a distal end port, incommunication with the lumen proximate the distal end; and a selectivedeflector positioned within the lumen, wherein the selective deflectoris configured to deflect a procedure catheter having a diameter greaterthan a preset threshold out through the side exit port, and wherein theselective deflector is configured to permit a guide catheter having adiameter of less than the preset threshold to pass distally beyond thedeflector and out through the distal end port.
 2. The access cathetersystem of claim 1, wherein the selective deflector comprises an inclinedbarrier positioned within and partially occluding the lumen.
 3. Theaccess catheter system of claim 2, wherein the inclined barrier includesan aperture.
 4. The access catheter system of claim 3, wherein theaperture has an aperture diameter smaller than a side exit port diameterof the side exit port.
 5. The access catheter system of claim 1, furthercomprising a laterally expandable support carried by the elongate,flexible tubular body, wherein the laterally expandable support ispositioned on an opposite side of the tubular body from the side exitport.
 6. The access catheter system of claim 5, wherein the laterallyexpandable support comprises an inflatable balloon.
 7. The accesscatheter system of claim 5, wherein the laterally expandable supportcomprises at least one laterally deflectable strut.
 8. The accesscatheter system of claim 1, further comprising a first occlusion balloonand a second occlusion balloon, wherein the first occlusion balloon ispositioned on the tubular body on a proximal side of the side exit portand the second occlusion balloon is positioned on the tubular body on adistal side of the side exit port.
 9. The access catheter system ofclaim 1, wherein the procedure catheter comprises at least one of aflexible needle, a steerable needle, a retractable needle sheath, aretractable guard, a dilator, a steerable catheter, an imaging device,an ablation device, force sensors, temperature sensors, biopsy device, acompressible-expandable biopotential sensing or stimulation device orimplant, a convection-enhanced drug delivery microcatheter, or aninjectable drug eluting bioresorbable nanofluidic implant.
 10. Theaccess catheter system of claim 9, wherein at least one of the ablationdevice or the imaging device comprises a microelectronic mechanicalsystem, optical technology, a flexible laser-cut hypotube, or co-axialactuating mechanical system.
 11. The access catheter system of claim 9,wherein the compressible-expandable biopotential sensing or stimulationdevice or implant comprises a shape memory scaffold embedded withelectrodes configured to transmit to a connector for recoding neurons,mapping cortical activity, stimulating neurons, or modulating corticalactivity.
 12. A method of providing transvascular access to anextravascular access site in a vessel, the method comprising the stepsof: advancing an access catheter over a guide to position a side exitport of the access catheter adjacent to a target site of the vessel;retracting the guide from the access catheter; and advancing a procedurecatheter through the access catheter and-to the target side of thevessel via the side exit port of the access catheter, wherein aselective deflector in the access catheter deflects the procedurecatheter out through the side exit port, but permits the guide toadvance distally beyond the deflector and out of a distal end of theaccess catheter.
 13. The method of claim 12, wherein advancing theaccess catheter over the guide comprises advancing the access catheterover a microcatheter.
 14. The method of claim 12, wherein advancing-theaccess catheter over the guide comprises advancing the access catheterover a guidewire.
 15. The method of claim 12, wherein the vesselcomprises a vein.
 16. The method of claim 12, further comprising:anchoring the access catheter to the target site by deploying expandablestructural members of the access catheter.
 17. The method of claim 12further comprising: deploying a procedure catheter or instrument throughthe side exit port; advancing a second device-across the vein and intothe target area, thereby creating a venous puncture site; advancing awire through the second device into the target area to deploy a secondprocedure catheter with advanced functionality; removing the seconddevice; and deploying supporting expandable structural elements of theaccess catheter.
 18. The method of claim 12, wherein the secondprocedure catheter with advanced functionality is configured to at leastone of collect or deliver media and tissue, locally image tissue,deliver materials, drug, or compounds, implant devices, record fromneurons, modulate neuronal activity, or ablate tissue.
 19. The method ofclaim 17, wherein deploying supporting expandable structural elements ofthe access catheter further comprises: repositioning the access cathetersuch that at least one balloon of the access catheter overlays thevenous puncture site; inflating at least one balloon of the accesscatheter such that it contacts the venous puncture site, therebytamponades the venous puncture site to produce hemostasis-; evaluatingif hemostasis has been achieved by deflating the at least one balloon ofthe access catheter; deploying an implantable biosynthetic,bioabsorbable hemostatic material from the side exit port responsive todetermining that hemostasis from balloon tamponade not being achieved.20. The method of claim 19, wherein the biosynthetic, bioabsorbablehemostatic material further comprises at least one of Poly (L) polymer,and Dextran-Sucrose-Sodium Citrate polymer.